| CTRI Number |
CTRI/2026/02/104923 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of two drugs in reducing morphine requirement in adult patients undergoing robotic operation in leg-up head-down position |
|
Scientific Title of Study
|
Comparison of Target controlled infusions of dexmedetomidine versus propofol for robot-assisted surgery in steep Trendelenberg position: A randomised clinical study. |
| 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 Shagun Bhatia Shah |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shagun Bhatia Shah |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shagun Bhatia Shah |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi 110085, India |
|
|
Primary Sponsor
|
| Name |
Dr Shagun Bhatia Shah |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini |
| 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 Shagun Bhatia Shah |
Rajiv Gandhi Cancer Institute and Research Centre |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
DELHI
North West
DELHI |
09891769779
drshagun_2010@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Target controlled infusion of dexmedetomidine |
During robot-assisted surgery in steep Trendelenberg position, Medcaptain infusion pump shall be used to administer dexmedetomidine after selecting the Hannivoort pharmacokinetic model, entering the age, gender, weight and height of the patient, with effect site concentration set at 1-2ng/ml, titrated to bispectral index 40-60. |
| Comparator Agent |
Target controlled infusion of propofol |
During robot-assisted surgery in steep Trendelenberg position, Medcaptain infusion pump shall be used to administer propofol after selecting the Eleveld pharmacokinetic model, entering the age, gender, and weight of the patient, with effect site concentration set at 2-4 µg/ml titrated to bispectral index 40-60. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Weighing 45-80kg
Posted for robot-assisted surgery in steep Trendelenberg position |
|
| ExclusionCriteria |
| Details |
Refusal to give consent
Egg allergy
Soy allergy
Raised intracranial pressure
Bradyarrhythmia
Deranged LFT
|
|
|
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 |
| Total opioid requirement |
5min after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total sevoflurane consumption |
At the end of surgery |
| Numeric Rating Scale score for pain |
2h, 4h, 6h, 8h, 12h, and 24h post surgery |
| Heart rate |
Baseline
Attaining effect site drug concentration
Intubation
5 min post intubation
Pneumoperitoneum
After 1min, 1h, 2h, 3h in Steep Trendelenberg position
1 min after supination |
| Mean arterial pressure |
Baseline
Attaining effect site drug concentration
Intubation
5 min post intubation
Pneumoperitoneum
After 1min, 1h, 2h, 3h in Steep Trendelenberg position
1 min after supination |
| Perfusion index |
Baseline
Attaining effect site drug concentration
Intubation
5 min post intubation
Pneumoperitoneum
After 1min, 1h, 2h, 3h in Steep Trendelenberg position
1 min after supination |
| Optic nerve sheath diameter |
Baseline
Attaining effect site drug concentration
Intubation
5 min post intubation
Pneumoperitoneum
After 1min, 1h, 2h, 3h in Steep Trendelenberg position
1 min after supination |
| Richmond agitation sedation score |
2h, 4h, 6h, 8h, 12h, and 24h post surgery |
| Post operative nausea and vomiting |
2h, 4h, 6h, 8h, 12h, and 24h post surgery |
| Length of surgical intensive care unit stay |
Shifting patient to ward orders |
| Total study drug consumption |
At the end of surgery |
| Complications |
Intraoperative period
Postoperative period |
|
|
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)
|
18/03/2026 |
| 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="0"
Months="8"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 [drshagun_2010@rediffmail.com].
- For how long will this data be available start date provided 08-08-2027 and end date provided 07-08-2030?
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
|
This prospective, interventional, single-centred, parallel arm, randomised controlled study aims to compare a target controlled infusion of dexmedetomidine with a target controlled infusion of propofol for an opioid sparing effect during robot-assisted surgery in steep Trendelenberg position at doses that maintain surgical depth of anesthesia (bispectral index 40-60). The study shall include 60 adult ASA I-II patients of either sex, aged 18-70 years, weighing 45-80 kg, undergoing robot-assisted surgery in steep Trendelenberg position. Patients who refuse to give consent, have egg allergy, soyabean allergy, bradyarrhythmias, raised intracranial pressure, glaucoma, or deranged hepatorenal function tests shall be excluded from the study. The study spanning 8 months shall be conducted at Rajiv Gandhi Cancer Institute and Research Centre, Delhi. Our primary outcome measure would be the difference in intraoperative opioid consumption between the two groups. Our secondary outcome measures would be the intraoperative sevoflurane consumption, the numeric rating scale score for pain, the Richmond agitation-sedation score, and postoperative nausea vomiting at 2h, 4h, 6h, 8h, 12h, and 24h post surgery, the heart rate, mean arterial pressure, perfusion index, and optic nerve sheath diameter measured at baseline, total study drug consumed intraoperatively, length of surgical intensive unit stay, and any complications in the intraoperative period and postoperative period. |