| CTRI Number |
CTRI/2026/01/101040 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing opioid free and opioid based anaesthesia for recovery and Pain control after Gynecological cancer surgery |
|
Scientific Title of Study
|
Comparison Of Opioid Based And Opioid free Anaesthesia Technique For Recovery Profile And Postoperative Analgesia In Patient Undergoing Gynecological Malignancy Surgery |
| 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 HARDIK TANEJA |
| Designation |
Postgraduate Resident |
| Affiliation |
Mahatma Gandhi Medical college and Hospital |
| Address |
OT Complex 2nd floor Depof Anaesthesia Mahatma Gandhi Medical College And Hospital RIICO Industrial Area Mahatma Gandhi Road Sitapura Jaipur Rajasthan 302022
RIICO Industrial Area Mahatma Gandhi Road Sitapura Jaipur Rajasthan 302022
Jaipur
RAJASTHAN
302022
India |
| Phone |
9896456466 |
| Fax |
|
| Email |
hardiktaneja99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HARDIK TANEJA |
| Designation |
Postgraduate Resident |
| Affiliation |
Mahatma Gandhi Medical college and Hospital |
| Address |
OT Complex 2nd floor Department of Anaesthesia Mahatma Gandhi Medical College And Hospital RIICO Industrial Area Mahatma Gandhi Road Sitapura Jaipur Rajasthan 302022
RIICO Industrial Area Mahatma Gandhi Road Sitapura Jaipur Rajasthan 302022
Jaipur
RAJASTHAN
302022
India |
| Phone |
9896456466 |
| Fax |
|
| Email |
hardiktaneja99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namita Gupta |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical college and Hospital |
| Address |
Ot complex 2nd Floor Department of Anaesthesia Mahatma Gandhi Medical College And Hospital RIICO Industrial Area Mahatma Gandhi Road Sitapura Jaipur 302022
RIICO Industrial Area Mahatma Gandhi Road Sitapura Jaipur Rajasthan 302022
Jaipur
RAJASTHAN
302022
India |
| Phone |
9462083676 |
| Fax |
|
| Email |
drnamita2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Hospital Sitapura Jaipur Rajasthan. |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Mahatma Gandhi Medical College and Hospital Sitapura Jaipur Rajasthan. |
| 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 HARDIK TANEJA |
Mahatma Gandhi Hospital |
OT complex 2nd floor Department Of Anaesthesia Mahatma Gandhi Hospital Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN |
9896456466
hardiktaneja99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe Mahatma Gandhi Medical College and Hospital Mahatma gandhi university of Medical Sciences and Technology, jaipur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C57||Malignant neoplasm of other and unspecified female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine infusion (loading dose 0.7 µg/kg over 10 min, followed by 0.3–0.4 µg/kg/hr infusion) |
Dexmedetomidine will be administered as a loading dose of 0.7 µg/kg IV over 10 minutes before induction of anaesthesia, followed by a continuous intravenous infusion at 0.3–0.4 µg/kg/hr. The infusion rate will be titrated in steps of 0.1 µg/kg/hr to maintain systolic blood pressure within ±20% of baseline. The infusion will be discontinued at the time of skin closure. All other anaesthesia management (induction, muscle relaxation, maintenance, and ventilation strategy) will remain identical to the intervention arm. |
| Intervention |
Dexmedetomidine-based anaesthesia (IV dexmedetomidine loading dose 0.7 µg/kg over 10 min followed by infusion 0.3–0.4 µg/kg/hr, titrated to SBP ±20% of baseline) |
Group 2: Dexmedetomidine)
Induction with propofol and rocuronium. Dexmedetomidine loading 0.7 µg/kg over 10 min followed by infusion 0.3 µg/kg/hr, adjustable in 0.1 µg/kg/hr increments to maintain SBP ±20% of baseline. |
| Comparator Agent |
Remifentanil infusion (1.5 µg/kg bolus followed by 0.2–0.24 µg/kg/min infusion) |
Remifentanil will be administered as a 1.5 µg/kg IV bolus before induction, followed by a continuous infusion at 0.2–0.24 µg/kg/min. The infusion rate will be adjusted in increments of 0.02 µg/kg/min to maintain systolic blood pressure within ±20% of baseline. The infusion will be discontinued after skin closure |
| Intervention |
Remifentanil-based anaesthesia (IV remifentanil bolus 1.5 µg/kg followed by infusion 0.2–0.24 µg/kg/min, titrated to SBP ±20% of baseline) |
Group 1: Remifentanil)
Induction with propofol and rocuronium. Remifentanil bolus 1.5 µg/kg followed by infusion 0.2 µg/kg/min, adjustable in 0.02 µg/kg/min increments to maintain SBP ±20% of baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA :
Patient giving consent to involve in study
Patient posted for elective gynaecological malignancy surgery needing general anaesthesia
Patient aged between 18-65 years
Patient with American Society of anaesthesiologists (ASA) Class 1 to Class 2
|
|
| ExclusionCriteria |
| Details |
BMI >35 kg/m2
Uncontrolled comorbidities viz. diabetes, hypothyroidism, hypertension etc.
H/O Cerebrovascular disease
Patient with known or newly diagnosed coagulopathy
Patient allergic to study drugs
Patient with american society of anesthesiology (ASA) classification 3 or more
Those schduled for undergoing emergency surgery.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objectives :To Assess total post operative analgesic consumption in 24 hours and time to first analgesic in opioid based and opioid free group. |
Just before induction (baseline)
5 minutes after induction
10 minutes after induction
15 minutes after induction
30 minutes after induction
60 minutes after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to eye opening,extubation time & time to shifting to PACU
NRS score at PACU admission
Time to PACU discharge criteria (modified aldrete score )
Time to PACU discharge criteria (modified aldrete score)
Incidence of complications. |
NRS pain score at PACU admission then every 15 minutes in PACU
Time to PACU discharge measured as the duration from arrival in PACU until Modified Aldrete Score equal to or more than 9 |
|
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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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/01/2026 |
| 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="6"
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
|
AIM Comparison between opioid based and opioid free anaesthesia technique for patient recovery profile and postoperative analgesia in patient undergoing gynecological malignancy surgeries
OBJECTIVES Primary objectives Primary objectives :To Assess total post operative analgesic consumption in 24 hours and time to first analgesic in opioid based and opioid free group.
Secondary objectives:
Time to eye opening,extubation time and time to shifting to PACU NRS score at PACU admission Time to PACU discharge criteria (modified aldrete score ) Incidence of complications.
INCLUSION CRITERIA :
Patient posted for elective gynaecological malignancy surgery needing general anaesthesia Patient aged between 18-65 years Patient with American Society of anaesthesiologists (ASA) Class 1 to Class 2
Exclusion Criteria:-
BMI >35 kg/m2 Uncontrolled comorbidities viz. diabetes, hypothyroidism, hypertension etc. H/O Cerebrovascular disease Patient with coagulation disorder Patient allergic to study drugs Patient with american society of anesthesiology (ASA) classification 3 or more Those schduled for undergoing undergoinemergency. Pregnant and lactating females
|