**2.3 Results (1)**

190 Patients were referred to us for endoscopy during the study period (Figure 1).

Fig. 1. Trial profile

We calculated that 105 subjects in each arm will give the study 80% power at an alpha of 0.05. We expected the percentage of subjects with good endoscopic vision to be 90% in R10 group compared to about 75% seen in our clinical practice (R6). The association between the different grades of endoscopic vision and period of fasting was assessed using the Extended Mantel-Haenszel X2 test for trend in Winpepi (Abramson, J.H. WINPEPI (PEPI-for-Windows): computer programs for epidemiologists. Epidemiologic Perspectives & Innovations 2004, 1:6). Kappa was used to calculate the degree of agreement between the endoscopist and the independent assessor who viewed the endoscopies. The p values are presented uncorrected

190 Patients were referred to us for endoscopy during the study period (Figure 1).

190 patients referred for endoscopy

128 patients were randomized

> 63 drinking water up to one hour (cases)

43 completed the trial (Group B)

65 fasting 6 hours (controls)

53 completed the trial (Group A)

5 drank water 7 refused endoscopy

Fig. 1. Trial profile

62 patients excluded 25 upper GI bleed 13 refused to participate 10 alarm symptoms 7 motility disorders 5 <18 or >65 years 2 pregnant

14 drank liquid other than water 6 refused endoscopy

**2.2.2 Statistics** 

for multiple testing.

**2.3 Results (1)** 

62 were excluded. 128 were randomized to the two interventions, 65 to nil by mouth (Group A) and 63 to those allowed to drink water according to their thirst for up to one hour prior to endoscopy (Group B). The two groups were comparable for age and gender (Table 3).

32 patients (12 in group A and 20 in group B) did not complete the study; 19 had not followed instructions regarding pre-endoscopy preparation, 13 refused endoscopy after randomization (Figure 1). 96 patients completed the study; 53 in group and 43 in group B. All patients in group B had consumed at least 200 ml water (range 200 to 410) before endoscopy. Discomfort due to fasting was significantly lower in group B than in group A. According to the endoscopist, endoscopic vision was good in all 53 patients in group A and 40 patients in group B, and average in 3 patients in group B. None were graded as poor. There was good agreement between the endoscopist and independent assessors who viewed the videos of the endoscopies (Kappa= 0.64) (Table 3).

Fluid in the gastric fundus was noted in 11 patients in group A and 16 in group B. There were no significant differences in volume or pH of the gastric aspirate between the two groups. There were no complications attributable to the endoscopy in either group.


Table 3. Demography and indication for endoscopy in patients

Evidence Based Guidelines for Preparation Before Upper Gastrointestinal Endoscopy (UGIE) 21

detect any complications, we admit that the numbers studied are too small to make firm conclusions regarding safety. As none of our patients were sedated, our results on safety

Although the American Society for Gastrointestinal Endoscopy guidelines for UGIE advices fasting for at least 4 hours for liquids1, we advised our controls to fast for 6 hours since this is the current practice in our unit, and some guidelines still advice 6 hours fasting for both solids and liquids. This may have had some effect on the degree of patient discomfort indicated by our controls. Another shortcoming in our study was the high drop out rate after randomization. Even though the instructions given were simple, several patients failed to follow them. Most patients who ultimately refused to undergo endoscopy expressed

Prolonged fasting for solids and clear liquids prior to endoscopy still remains in many guidelines1. Prolonged fasting for clear fluids is illogical because the stomach secretes up to 50ml of acidic fluid per hour even in the fasting state, and empties rapidly after ingestion of clear fluids14. This would explain why the volume and pH of gastric aspirate was similar in the two groups in our study; the fluid aspirated in Group B was more likely to be gastric secretion than any residual ingested water15. Endoscopic vision is affected when patients drink milk16. For this reason we allowed our patients to drink only water. To maximize practicalities we allowed them to drink water according to their thirst. As various types of food can affect the rate of gastric emptying we used a standard meal11. We also attempted to

In conclusion allowing patients to drink water for up to one hour prior to endoscopy together with a 6-hour fast for solids seems to be preferred by patients, and does not hamper endoscopic vision. Two studies done on two different populations more than ten years apart

We recommend that current guidelines on preparation for patients undergoing UGIE be

Our second study shows that fasting for 6 hours after a rice based meal is inadequate to provide good vision during UGIE. Fasting for 10 hours significantly improves endoscopic vision. Our finding has several implications. Firstly, if patients consume a rice meal and fast for six hours they may be potentially at risk for aspiration. Although we did not encounter this complication, we admit that the numbers studied were too small to make firm conclusions regarding safety. Secondly, poor vision would hamper detection of lesions and would necessitate repeating the procedure. Thirdly, endoscopist may wrongly assume that these patients have slow gastric emptying and subject them to unnecessary and costly investigations. Our study also has implications for patients being prepared for general anaesthesia before surgery as none of the anaesthetic guidelines specify the period of fasting

In an attempt to reduce individual bias as much as possible two operators performed all the endoscopies. We also attempted to reduce observer bias by having another independent assessor. The agreement between them was good, and whenever there was any disagreement on endoscopic vision grading between the endoscopist and the independent assessor, the lower grading was used. We did not attempt to measure the volume of left over food in the

In conclusion, patients consuming a rice based meal prior to UGIE need to fast for at least ten hours prior to the procedure in order to obtain good endoscopic vision Current guidelines need to be re-evaluated for populations where rice is the staple diet, and this is

may not be applicable to situations where sedation prior to endoscopy is routine.

eliminate observer bias by having two other independent assessors.

apprehension regarding the procedure.

have now shown similar results5.

required after a rice based meal17.

especially important in the Asian setting.

reviewed.

stomach.

#### **2.4 Results (2)**

A total of 335 patients were referred to us for endoscopy during the study period. Of these, 123 were excluded (61 had upper GI bleeding, 23 did not give consent, 15 had alarm symptoms, 6 had motility problems, 5 were <18 years or >65 years old, 8 not able to comply with the request for cessation of medication, 5 were pregnant). 212 patients were randomized to the two interventions: 107 to the R10 group and 105 to the R6 group. The two groups were comparable for age, gender and indications for enoscopy (Table 4). In the R10 group endoscopic vision was graded as poor in 2 (1.9%), average in 7 (6.5%), and good in 98 (91.5%), while in the R6 group it was graded as poor in 30 (28.6%), average in 19 (18.1%), good in 56 (53.3%). The observed difference of percentages among the two groups for endoscopic vision was significant (M-H Chi-Square for trend=25.67; df=1; P<0.001). There was good agreement between the endoscopists and the independent assessor who witnessed the endoscopies (Kappa = 0.97). There were no immediate or late complications due to endoscopy.


\*Based on Pearson Chi-square Value

\*\*Based on Extended Mantel-Haenszel X2 test for trend

Table 4. Endoscopic findings of patients

#### **3. Conclusions**

We have shown that a 6-hour fast for solids and one-hour fast for water prior to UGIE, gives good endoscopic vision and causes minimum patient discomfort. This confirms the results of an earlier study done more than 10 years ago12,13. Our study was designed mainly to assess the quality of endoscopic vision and patient discomfort. Even though we did not

A total of 335 patients were referred to us for endoscopy during the study period. Of these, 123 were excluded (61 had upper GI bleeding, 23 did not give consent, 15 had alarm symptoms, 6 had motility problems, 5 were <18 years or >65 years old, 8 not able to comply with the request for cessation of medication, 5 were pregnant). 212 patients were randomized to the two interventions: 107 to the R10 group and 105 to the R6 group. The two groups were comparable for age, gender and indications for enoscopy (Table 4). In the R10 group endoscopic vision was graded as poor in 2 (1.9%), average in 7 (6.5%), and good in 98 (91.5%), while in the R6 group it was graded as poor in 30 (28.6%), average in 19 (18.1%), good in 56 (53.3%). The observed difference of percentages among the two groups for endoscopic vision was significant (M-H Chi-Square for trend=25.67; df=1; P<0.001). There was good agreement between the endoscopists and the independent assessor who witnessed the endoscopies (Kappa = 0.97). There were no immediate or late complications due to endoscopy.

**Variable R6 (n=105) R10 (n=107) X2 P value** 

GERD 22 (21.1%) 19 (17.8%) 0.347 0.556\* Gastritis 29 (27.6%) 36 (33.6%) 0.905 0.341\* Peptic Ulcers 12 (11.4%) 12 (11.2%) 0.002 0.961\* Bile reflux 1 (0.9%) 1 (0.9%) 0.000 0.989\* Any other pathology 3 (2.8%) 7 (6.5%) 1.601 0.206\* Normal 38 (36.2%) 32 (29.9%) 0.946 0.331\*

We have shown that a 6-hour fast for solids and one-hour fast for water prior to UGIE, gives good endoscopic vision and causes minimum patient discomfort. This confirms the results of an earlier study done more than 10 years ago12,13. Our study was designed mainly to assess the quality of endoscopic vision and patient discomfort. Even though we did not

Good 98 (91.6%) Average 7 (6.5%) Poor 2 (1.9%)

Good 99 (92.5%) Average 6 (5.6%) Poor 2 (1.9%)

21 (20.0%) 25 (22.9%) 0.353 0.552\*

41.478 <0.0001\*\*

39.985 <0.0001\*\*

Average 19 (18.1%) Poor 30 (28.6%)

Average 19 (18.1%) Poor 28 (26.7%)

**2.4 Results (2)** 

Endoscopic vision

Number of Patients with fluid in the gastric fundus (%)

Principal endoscopic diagnosis (%)

\*Based on Pearson Chi-square Value

**3. Conclusions** 

Table 4. Endoscopic findings of patients

\*\*Based on Extended Mantel-Haenszel X2 test for trend

Endoscopist Good 56 (53.3%)

Independent Assessor Good 58 (55.2%)

detect any complications, we admit that the numbers studied are too small to make firm conclusions regarding safety. As none of our patients were sedated, our results on safety may not be applicable to situations where sedation prior to endoscopy is routine.

Although the American Society for Gastrointestinal Endoscopy guidelines for UGIE advices fasting for at least 4 hours for liquids1, we advised our controls to fast for 6 hours since this is the current practice in our unit, and some guidelines still advice 6 hours fasting for both solids and liquids. This may have had some effect on the degree of patient discomfort indicated by our controls. Another shortcoming in our study was the high drop out rate after randomization. Even though the instructions given were simple, several patients failed to follow them. Most patients who ultimately refused to undergo endoscopy expressed apprehension regarding the procedure.

Prolonged fasting for solids and clear liquids prior to endoscopy still remains in many guidelines1. Prolonged fasting for clear fluids is illogical because the stomach secretes up to 50ml of acidic fluid per hour even in the fasting state, and empties rapidly after ingestion of clear fluids14. This would explain why the volume and pH of gastric aspirate was similar in the two groups in our study; the fluid aspirated in Group B was more likely to be gastric secretion than any residual ingested water15. Endoscopic vision is affected when patients drink milk16. For this reason we allowed our patients to drink only water. To maximize practicalities we allowed them to drink water according to their thirst. As various types of food can affect the rate of gastric emptying we used a standard meal11. We also attempted to eliminate observer bias by having two other independent assessors.

In conclusion allowing patients to drink water for up to one hour prior to endoscopy together with a 6-hour fast for solids seems to be preferred by patients, and does not hamper endoscopic vision. Two studies done on two different populations more than ten years apart have now shown similar results5.

We recommend that current guidelines on preparation for patients undergoing UGIE be reviewed.

Our second study shows that fasting for 6 hours after a rice based meal is inadequate to provide good vision during UGIE. Fasting for 10 hours significantly improves endoscopic vision. Our finding has several implications. Firstly, if patients consume a rice meal and fast for six hours they may be potentially at risk for aspiration. Although we did not encounter this complication, we admit that the numbers studied were too small to make firm conclusions regarding safety. Secondly, poor vision would hamper detection of lesions and would necessitate repeating the procedure. Thirdly, endoscopist may wrongly assume that these patients have slow gastric emptying and subject them to unnecessary and costly investigations. Our study also has implications for patients being prepared for general anaesthesia before surgery as none of the anaesthetic guidelines specify the period of fasting required after a rice based meal17.

In an attempt to reduce individual bias as much as possible two operators performed all the endoscopies. We also attempted to reduce observer bias by having another independent assessor. The agreement between them was good, and whenever there was any disagreement on endoscopic vision grading between the endoscopist and the independent assessor, the lower grading was used. We did not attempt to measure the volume of left over food in the stomach.

In conclusion, patients consuming a rice based meal prior to UGIE need to fast for at least ten hours prior to the procedure in order to obtain good endoscopic vision Current guidelines need to be re-evaluated for populations where rice is the staple diet, and this is especially important in the Asian setting.

**3** 

*Romania* 

Mitrut Paul, Mitrut Anca Oana,

Streba Liliana, Calina Daniela and Salplahta Daniel

*University of Medicine and Pharmacy of Craiova* 

**Sedation Related to Gastrointestinal Endoscopy** 

In the last ten years the number of worldwide gastrointestinal endoscopic procedures has significantly increased; the majority are ambulatory endoscopies with appropriate intravenous sedation and analgesia which seems to be used more and more frequent. By definition, sedation is a drug-induced depression in the level of consciousness. Moderate sedation current terminology replaces the previous terminology called conscious sedation (American Society of Anesthesiologists [ASA], 2002). Sedation and analgesia are being used in order to improve patient tolerance to endoscopic procedures by diminishing anxiety and discomfort. There are several sequent benefits: an adequate sedation allows the endoscopist to focus on the technical performance of the endoscopy, increases the rate of patients returning for follow-up examinations or for colonoscopic screening, prevents potentially harmful autonomic stress responses and improves the public reputation of the procedure. However, these benefits must be weighed against the complications (especially in the form of potential compromise of ventilatory function) and the added cost associated with the use

Patients with associated comorbidities address to the gastroscopist to perform an endoscopy without being evaluated for their pathologies that could influence the procedures used in sedation. In addition, in cases where the examination is more invasive or conducted in a larger time interval, the level of sedation should be optimized to achieve an ideal procedure

The practice of sedation varies from country to country, determined by cultural differences in pain perception and expectations of patients and physicians. A recent international study of 21 centers in 10 European countries and in Canada reported that the use of sedation during endoscopy varies from 0% to 100% at different sites: it was used in 44% of all procedures in Asia, 56% in Europe, and 72% in Canada, Central America and South Latin America. In the United States, only flexible sigmoidoscopy is performed without sedation (Wang&Lin, 1999). Such diversity reflects social, cultural, regulatory and economic

Best practices for analgesia and sedation during gastrointestinal endoscopy are still debated. Ensuring an adequate sedation and analgesia influences some aspects of endoscopic procedures such as quality of examination, patient cooperation, patient and performing

There are several practical issues with implications for endoscopic sedation (Thomson *et al*.,

**1. Introduction** 

of sedation and analgesia.

(ASA, 2002; Faigel *et al*., 2002).

physician satisfaction (Bell, 2004).

consideration.

2010):

Based largely on the evidence of our studies we have suggested that the following guidelines be used before for preparation for upper GI endoscopy in the Asian setting.


#### **4. References**


http//www.fao.org/docret/011/ai474e/ai474e05.htm (Accessed 10 January 2009).

