| CTRI Number |
CTRI/2025/11/097138 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to determine the best fluid therapy during surgery for patients undergoing gynecological surgeries |
|
Scientific Title of Study
|
Liberal versus Restrictive Fluid Management in Ambulatory Laparoscopic Gynaecological Surgeries: A Randomized 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 RAM SINGH |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Anesthesiology Pain Medicine and Critical Care
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9958311829 |
| Fax |
|
| Email |
dr.ram2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAM SINGH |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Anesthesiology Pain Medicine and Critical Care
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9958311829 |
| Fax |
|
| Email |
dr.ram2001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAM SINGH |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Anesthesiology Pain Medicine and Critical Care
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9958311829 |
| Fax |
|
| Email |
dr.ram2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Anasri nagar New Delhi India PIN 110029 |
|
|
Primary Sponsor
|
| Name |
DR RAM SINGH |
| Address |
Department of anesthesiology Pain Medicine and Critical care
AIIMS New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 RAM SINGH |
All India Institute of Medical Sciences New Delhi |
Department of Anesthesiology Pain Medicine and Critical Care
AIIMS New Delhi
South
DELHI |
09958311829
dr.ram2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N849||Polyp of female genital tract, unspecified, (2) ICD-10 Condition: N709||Salpingitis and oophoritis, unspecified, (3) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified, (4) ICD-10 Condition: N74||Female pelvic inflammatory disorders in diseases classified elsewhere, (5) ICD-10 Condition: N809||Endometriosis, unspecified, (6) ICD-10 Condition: N839||Noninflammatory disorder of ovary,fallopian tube and broad ligament, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraoperative Libral Fluid Management |
Intraoperative Libral fluid administration (40ml/kg) for 1 hour followed by 2ml/kg for the remaining intraoperative period |
| Intervention |
Intraoperative Restrictive Fluid Management |
Intraoperative Libral fluid administration (15 ml/kg) for 1 hour followed by 1ml/kg for the remaining intraoperative period |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 ASA I-II
2 Duration of surgery less than 90 minutes
3 Diagnostic laparoscopy and hysteroscopy
4 Minor laparoscopic procedure
|
|
| ExclusionCriteria |
| Details |
1 Patient refusal
2 Hemoglobin level less than 10gm percent
3 Known cardiac or renal disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to attain hospital discharge criteria |
Time in minutes from arrival in PACU to discharge readiness with Modified PADDS score of 9 or more |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain |
Pain using Visual Analogue Scale of 100 mm on arrival at PACU and at Discharge |
| Postoperative Nausea and Vomiting PONV |
PONV score using a 0 to 3 PONV score on arrival in PACU and at discharge |
| Presence or absence of dizziness fatigue and thirst |
Recorded as binary response Yes/No on arrival in PACU and at Discharge |
| Modified PADSS score for discharge readiness |
On Arrival in PACU and At Discharge |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/12/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.ram2001@gmail.com].
- For how long will this data be available start date provided 15-09-2027 and end date provided 15-09-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Optimal perioperative fluid management is an ongoing challenge in anaesthesia practice. While liberal fluid administration has been traditionally recommended to compensate for preoperative fasting and surgical stress, concerns remain regarding potential fluid overload and delayed recovery. Conversely, restrictive regimens, though widely adopted in major abdominal and thoracic surgeries, may risk inadequate tissue perfusion. The applicability of these findings to short-duration, ambulatory laparoscopic gynaecological procedures remains uncertain. Day-care surgeries demand rapid recovery, minimal postoperative symptoms, and early discharge. Small studies in minor surgery suggest that intravenous fluid therapy can reduce dizziness, thirst, fatigue, and nausea, thereby improving patient comfort and recovery. However, evidence remains inconsistent, and there are no clear guidelines on the optimal intraoperative fluid regimen for this subset of patients. This randomized controlled trial aims to compare liberal versus restrictive intraoperative fluid administration in ambulatory laparoscopic gynaecological surgery, focusing on time to discharge readiness and patient-centred recovery outcomes. The study is expected to generate robust evidence that will inform perioperative practice and enhance patient safety, satisfaction, and efficiency of ambulatory care. |