| CTRI Number |
CTRI/2025/12/098344 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare blood pressure changes between 2 novel anesthesia delivery modalities in adult patients undergoing elective laparoscopic surgery |
|
Scientific Title of Study
|
Comparison of mean blood pressure variability in conox-guided total intravenous anaesthesia and closed-loop anaesthesia delivery system in adult patients undergoing elective laparoscopic surgery: a randomized control 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 Manoj Kamal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences Jodhpur, Marudhar Industrial Area, Phase II, Basni, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9414084584 |
| Fax |
|
| Email |
geetamanoj007@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kamal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9414084584 |
| Fax |
|
| Email |
geetamanoj007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Freddie Flavian Cruz S |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9176155890 |
| Fax |
|
| Email |
drfreddieflavian@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur, Rajasthan. INDIA 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
All India Institute of Medical Sciences (AIIMS) Phase II Basni Industrial Area
Jodhpur Rajasthan (India) 342005
|
| 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 Manoj Kamal |
AIIMS JODHPUR |
Department of Anaesthesiology and Critical
Care, 3rd floor, DnT block, All India
Institute of Medical Sciences (AIIMS),
Phase II, Basni Industrial Area, Jodhpur
Jodhpur
RAJASTHAN |
9414084584
geetamanoj007@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Jodhpur |
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 |
GROUP A (CONOX guided TIVA) |
Anaesthesia will be delivered using Conventional TIVA under the guidance of CONOX monitoring and intraoperative hemodynamics and patient responses will be monitored.
Total Intravenous Anaesthesia will be Propofol and Fentanyl continous intravenous infusions of 10mg/ml and 10mcg/ml respectively. Dose will be on weight based calculation of standard infusion doses namely 150-250mcg/kg/min for propofol and 1-2mcg/kg/hr for fentanyl infusion throughout the duration of surgical procedure |
| Comparator Agent |
GROUP B (CLADs TIVA) |
Anaesthesia will be provided by the closed loop anaesthesia device (CLADs) and intraoperative hemodynamics and patient responses will be monitored.Total Intravenous Anaesthesia will be Propofol and Fentanyl continous intravenous infusions of 10mg/ml and 10mcg/ml respectively. Dose will be based on weight and height based calculation of in built CLADS algorithm throughout the duration of surgical procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
a. Adult patients ( more than 18 years)
b. Undergoing elective laparoscopic surgery requiring general anesthesia for more than 120 minutes
c. ASA (American society of anesthesiologists) physical status 1-3
|
|
| ExclusionCriteria |
| Details |
Known allergies to propofol, fentanyl, or other anesthetics
b. Significant cardiovascular, respiratory, neurological disorders, or uncontrolled endocrine diseases
c. Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate intraoperative hemodynamic stability, specifically mean arterial pressure (MAP), during elective laparoscopic surgeries, with a target MAP variation of ±25% from baseline in CONOX-guided Total Intravenous Anaesthesia (TIVA) and BIS-monitored Closed-Loop Anesthesia Delivery Systems (CLADS). |
Throughout duration of intraoperative period at 5 minutes intervals from induction to extubation, study to be conducted over a period of 1 year from date of approval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Heart Rate Variability:
To evaluate intraoperative heart rate variability (±25% from baseline) every 5 minutes as an indicator of autonomic stability & anesthetic effects.
2. Time to Extubation:
To compare the time to extubation, reflecting the recovery profile & anesthesia depth.
3. Modified Aldrete Score (Recovery Profile):
To assess postoperative recovery using the Modified Aldrete Score, evaluating consciousness, motor function, & vital signs.
4. Incidence of Postoperative Nausea & Vomiting (PONV):
To compare the incidence of PONV between the two anesthetic techniques.
5. Overall Propofol & Fentanyl Consumption:
To assess the total consumption of propofol & fentanyl, comparing drug usage between CONOX-guided TIVA & BIS-monitored CLADS.
|
Heart rate variability at every 5 minutes interval intraoperatively & time to extubation to be measured at the end of surgery to extubation of the trachea.
Modified Aldrete score Drug consumption PONV occurence in immediate post operative & 1 hour from end of surgery.
The study will be conducted over period of 1 year from enrollment date. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
13/12/2025 |
| 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="2"
Months="0"
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 study is a randomized, double blinded, single centre trial comparing the mean blood pressure variability in CONOX guided TIVA and CLADS based TIVA in patients undergoing elective laparoscopic surgery that will be conducted in DNT OT of AIIMS Jodhpur over a period of 1 year. The primary outcome is to evaluate intraoperative heomdynamic variability as measured by Mean Arterial Pressure in both groups. Secondary outcomes would be heart rate variability, time to extubation, modified aldrete score, propofol and fentanyl drug consumption, incidence of PONV in both groups. Both primary and secondary outcomes will be assessed after a period of 1 year for 52 cases for each group |