| CTRI Number |
CTRI/2024/12/078083 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Oral Carbohydrate fluid will be given before procedure under Anaesthesia] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial in cirrhotic patients to see Gastric emptying time after clear carbohydrate fluid
administration undergoing endoscopic procedures under
Anaesthesia, to help improve perioperative wellbeing. |
|
Scientific Title of Study
|
Gastric emptying time after clear fluid
administration in cirrhotic patients undergoing endoscopic procedures under
Anaesthesia: A randomised controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Heena Saghavi |
| Designation |
Senior Resident |
| Affiliation |
Institute of Liver and Biliary Sciences, New Delhi |
| Address |
Dept of Anaesthesiology, phase 2, 3rd floor, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi
South DELHI 110070 India |
| Phone |
|
| Fax |
|
| Email |
heenasanghavi2504@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepak Tempe |
| Designation |
Head of Department |
| Affiliation |
Institute of Liver and Biliary Sciences, New Delhi |
| Address |
Dept of Anaesthesiology, phase 2, 3rd floor, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi
South DELHI 110070 India |
| Phone |
9718599401 |
| Fax |
|
| Email |
tempedeepak@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepak Tempe |
| Designation |
Head of Department |
| Affiliation |
Institute of Liver and Biliary Sciences, New Delhi |
| Address |
Dept of Anaesthesiology, phase 2, 3rd floor, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi
South DELHI 110070 India |
| Phone |
9718599401 |
| Fax |
|
| Email |
tempedeepak@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology, 3rd floor, phase 2, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi 110070 |
|
|
Primary Sponsor
|
| Name |
Institue of Liver and Biliary Sciences. |
| Address |
Dept of Anaesthesiology, 3rd floor, phase 2, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi- 110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Heena Sanghavi |
Institute of Liver and Biliary Sciences |
Dept of Anaesthesiology, phase 2, 3rd floor, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi 110070 South DELHI |
07798630238
heenasanghavi2504@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 hours fasting group |
65 Patients of this group will receive oral clear 250ml apple juice and gastric ultrasound will be done after 2 hours to look for gastric emptying, then endoscopy will be done if empty, if not, hourly gastric ultrasound will be done, till stomach is empty. |
| Comparator Agent |
3 hours fasting group |
65 Patients of this group will receive oral clear 250ml apple juice and gastric ultrasound will be done after 3 hours to look for gastric emptying, then endoscopy will be done if empty, if not, hourly gastric ultrasound will be done, till stomach is empty. |
| Comparator Agent |
more than 6 hours fasting group |
65 Patients of this control group will not receive oral juice and directly gastric ultrasound will be done for gastric emptying, then endoscopy will be done if empty, if not, hourly gastric ultrasound will be done, till stomach is empty. |
| Intervention |
Oral carbohydrate fluid will be given in 3 groups. |
3 groups- 6 hours, 3 hours, 2 hours fasting group will undergo ultrasound for gastric emptying before endoscopic procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cirrhotic patients,
Patients undergoing Endoscopy, Endoscopic retrograde cholangiopancreatography, Endoscopic ultrasound. |
|
| ExclusionCriteria |
| Details |
Acute variceal bleed
Hepatic encephalopathy
Diabetes Mellitus
Patient refusal.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare gastric emptying time in 3 groups |
From 6 hours before procedure to 1 hour post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient well-being,
Hemodynamic status,
Postoperative complications |
Upto 1 hour postoperatively |
|
|
Target Sample Size
|
Total Sample Size="195" Sample Size from India="195"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prior to procedure, a brief pre-anaesthetic evaluation will be done. Intravenous access will be secured. Patients will be randomly assigned to one of the 3 groups: the control group (>6 hours), and intervention groups of 2 h and 3 h (n = 65 each). The intervention group will receive 250ml carbohydrate fluid (apple juice) 2 h or 3h prior to the scheduled endoscopic procedure, and control group will receive nothing. Preoperative wellbeing will be assessed, and Gastric ultrasound will be done in supine and right lateral position. Perioperative patient wellbeing will be assessed as VAS score for- Thirst, Hunger, Headache, Nausea/ vomiting, Weakness/ fatigue and Dryness of mouth. Gastric volume will be predicted by 3-point grading system grade 0- empty stomach (empty antrum in both the supine and right lateral positions) grade 1- minimal fluid < 100ml (volume detected only in the right lateral position) grade 2 - higher fluid volumes (>100 ml) antrum distended with fluid in both supine and right lateral positions, higher risk of regurgitation of gastric contents on induction of anaesthesia Grade 1 and 2 patients will be assessed again after 1 hr and will be taken after Grade 0. Grade 0 patients will be taken for procedure. In the endoscopy room, standard monitoring devices will be attached. Oxygen supplementation at 4 L/min will be administered through nasal cannula. With the patients in the left lateral position, induction will be done with intravenous propofol (1.5-2 mg/kg). Endoscopy will be performed and fluid if present, will be aspirated and calculated. Gastric fluid >/= 1.5ml/kg will be considered as high risk for bronchoaspiration. Intraprocedural Hemodynamics will be assessed at 0, 1 and 5 mins by measuring mean arterial pressure (MAP), SpO2, and HR. Patients will be assessed post procedure for any complications and patient wellbeing in terms of thirst, hunger, headache, nausea, vomiting, weakness, fatigue and dryness of mouth. |