| CTRI Number |
CTRI/2026/01/101673 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of intraoperative fentanyl dose on postoperative stomach contents measured by ultrasound |
|
Scientific Title of Study
|
Correlation between Intra-Operative Fentanyl Dosage with Post-Operative Gastric Residual Volume in Patients Posted for Hysteroscopic Surgery Using Gastric Ultrasound |
| 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 Mallika Boishya |
| Designation |
Secondary DNB Trainee |
| Affiliation |
Medanta The Medicity, Gurugram |
| Address |
Belguriapara, vill. Mirzapur, PS
:AZARA, Guwahati, 17, Assam
Sector 38, Gurugram, Haryana
Kamrup
ASSAM
781017
India |
| Phone |
7427813968 |
| Fax |
|
| Email |
mituboishya1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mallika Boishya |
| Designation |
Secondary DNB Trainee |
| Affiliation |
Medanta The Medicity, Gurugram |
| Address |
Belguriapara, vill. Mirzapur, PS
:AZARA, Guwahati, 17, Assam
Sector 38, Gurugram, Haryana
Kamrup
ASSAM
781017
India |
| Phone |
7427813968 |
| Fax |
|
| Email |
mituboishya1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mallika Boishya |
| Designation |
Secondary DNB Trainee |
| Affiliation |
Medanta The Medicity, Gurugram |
| Address |
Belguriapara, vill. Mirzapur, PS
:AZARA, Guwahati, 17, Assam
Sector 38,, Gurugram, Haryana
Kamrup
ASSAM
781017
India |
| Phone |
7427813968 |
| Fax |
|
| Email |
mituboishya1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Medanta Ethics Committee |
| Address |
Medanta The Medicity, Sector 38, Gurugram |
| 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 Mallika Boishya |
Medanta The Medicity |
Dr Mallika Boishya, Secondary DNB trainee, General Anesthesia, Sector 38
Gurgaon
HARYANA |
7427813968
mituboishya1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraoperative fentanyl |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade I, II, III undergoing hysteroscopic surgery |
|
| ExclusionCriteria |
| Details |
Patients less than 18 years and more than 65 years of age. Pregnant patients. Patients with morbid obesity (BMI more than 40 kg/m2). ASA IV. History of chronic pain/ or opioid usage. History of delayed gastric emptying. Patients on treatment with antacids, prokinetics or with history of acid peptic disease or gastric reflux. Pre-operative gastric residual volume more than 1.5ml/kg. Refusal for consent. Allergy /sensitivity to study drugs.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of intra-operative fentanyl less than and equal to 2 mcg/kg with post-operative gastric residual volume in hysteroscopic surgery using abdominal ultrasound for GRV monitoring. |
Baseline, postoperative 1 hour, 2 hours, and 3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of Age, VAS score, ASA Grading, type of surgery, duration of surgery, anesthesia technique, BMI with post-operative gastric residual volume, to identify predictors of intolerance or patients with high GRV |
1 hour post operative |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a prospective observational study designed to evaluate the relationship between intraoperative fentanyl dosage and postoperative gastric residual volume. Female patients undergoing elective hysteroscopic surgery under general anesthesia will be included. Fentanyl will be administered as part of standard anesthesia care and the total cumulative dose will be recorded. Postoperative gastric residual volume will be assessed using gastric ultrasound after 1 hour postoperative. The study aims to determine whether intraoperative fentanyl doses of less than 2 micro gram per kg body weight is associated with increased postoperative gastric residual volume. |