| CTRI Number |
CTRI/2026/01/102564 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two drugs, dexmedetomidine and propofol, for better oxygenation and reduced blood pressure changes in adult patients undergoing lung surgery |
|
Scientific Title of Study
|
Comparison of Target controlled infusion (TCI) of dexmedetomidine versus TCI propofol for one lung ventilation: A randomised clinical study |
| Trial Acronym |
TCIDPOL |
|
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
North West
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
North West
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 |
|
|
Primary Sponsor
|
| Name |
Dr Shagun Bhatia Shah |
| Address |
The specified URL is inaccessible at this time. Please try after some time |
| 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 |
Operation Theatre no:4;Department of Anaesthesia;Operation Theatre Division; Third Floor ;Old Building; Sector-5;Rohini;Delhi-110085
North West
DELHI |
09891769779
drshagun_2010@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IInstitutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre |
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 one lung ventilation, 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 one lung ventilation, 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, Undergoing lung resection surgery under one lung ventilation |
|
| ExclusionCriteria |
| Details |
Patient refusal to give consent, Egg allergy, Bradyarrhythmias, Respiratory dysfunction, Hepatorenal dysfunction, Posted for bilateral resection of pulmonary lesions or pneumonectomy |
|
|
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 |
| Change in the arterial partial pressure of oxygen (delta PaO2) |
60 minutes after initiation of one lung ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate |
Baseline, just before one lung ventilation (OLV), 30 min after one lung ventilation initiation, 60 min after one lung ventilation initiation, 90 min after initiation of one lung ventilation and at the end of surgery |
| Mean Arterial Pressure |
Baseline, just before one lung ventilation (OLV), 30 min after one lung ventilation initiation, 60 min after one lung ventilation initiation, 90 min after initiation of one lung ventilation and at the end of surgery |
| Perfusion Index |
Baseline, just before one lung ventilation (OLV), 30 min after one lung ventilation initiation, 60 min after one lung ventilation initiation, 90 min after initiation of one lung ventilation and at the end of surgery |
| Arterial partial pressure of oxygen |
Baseline, just before one lung ventilation (OLV), 30 min after one lung ventilation initiation, 60 min after one lung ventilation initiation, 90 min after initiation of one lung ventilation and at the end of surgery |
| Dynamic compliance |
Baseline, just before one lung ventilation (OLV), 30 min after one lung ventilation initiation, 60 min after one lung ventilation initiation, 90 min after initiation of one lung ventilation and at the end of surgery |
| Arterial partial pressure of carbon di oxide |
Baseline, just before one lung ventilation (OLV), 30 min after one lung ventilation initiation, 60 min after one lung ventilation initiation, 90 min after initiation of one lung ventilation and at the end of surgery |
| Number of complications |
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)
|
19/02/2026 |
| 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="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 - 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 - 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 28-12-2027 and end date provided 28-12-2030?
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, parallel-arm, single-centred, randomised controlled study aims to compare the effectiveness of a target-controlled infusion of dexmedetomidine with a target-controlled infusion of propofol for the prevention of hypoxemia during one-lung ventilation at doses that maintain surgical depth of anaesthesia (bispectral index 40-60). The study shall include 60 adult patients aged 18-70 years, weighing 45-80kg, undergoing lung resection surgery under one lung ventilation. Patients who refuse to give consent, have egg allergy, bradyarrhythmias, respiratory or hepatorenal dysfunction, or are posted for bilateral resection of lung lesions, or pneumonectomy shall be excluded from the study. The study, spanning six months, shall be conducted at Rajiv Gandhi Cancer Institute and Research Centre. The patients shall be randomly allocated to two groups dexmedetomidine group (Group D; n = 30) and propofol group (Group P; n = 30). Our primary outcome measure would be the difference in arterial partial pressure of oxygen (PaO2) recorded at baseline, and PaO2 recorded 60 min after initiation of one-lung ventilation. Our secondary outcomes would be the PaO2, PaCO2, heart rate, mean arterial pressure, perfusion index, and dynamic compliance measured at specific time points (baseline, two lung ventilation just before one lung ventilation, 30 min, 60 min and 90 min after initiation of one lung ventilation, end surgery). Intraoperative cardiac and pulmonary complications, postoperative pulmonary complications and Clavien-Dindo major complications shall also be noted. |