| CTRI Number |
CTRI/2025/07/090854 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to compare different doses Dexmeditomidine in reducing haemodynamic in reducing haemodynamic response in laparoscopic surgeries. |
|
Scientific Title of Study
|
A Randomised Prospective Comparative study of different doses of Dexmeditomidine in attenuating in haemodynamic response to pneumoperitoneum and post operative recovery in patients undergoing laparoscopic surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaithra V P |
| Designation |
Postgraduate, Department of Anaesthesiology |
| Affiliation |
Mysore medical college and research institute |
| Address |
Department of Anaesthesia, 2nd floor, Stone building ,Mysore medical college and Research institute, Irwin road, Mysuru, Karnataka
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
7795209749 |
| Fax |
|
| Email |
chaithravp.1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kokila N |
| Designation |
Associate professor, Department of Anaesthesiology. |
| Affiliation |
Mysore medical college and Research institute. |
| Address |
Department of Anesthesia,2nd floor, Stone building,Mysore medical college and Research institute, Irwin road, Mysuru, Karnataka
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
9902357802 |
| Fax |
|
| Email |
kokila222008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kokila N |
| Designation |
Associate professor, Department of Anaesthesiology. |
| Affiliation |
Mysore medical college and Research institute. |
| Address |
Department of Anaesthesia,2nd floor,Stone building,Mysore medical college and Research institute, Irwin road, Mysuru, Karnataka
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
9902357802 |
| Fax |
|
| Email |
kokila222008@gmail.com |
|
|
Source of Monetary or Material Support
|
| KR hospital, Irwin road, Devaraja Mohalla, Mysore, Karnataka 570001 |
|
|
Primary Sponsor
|
| Name |
Chaithra V P |
| Address |
Mysore medical college and Research institute, Irwin road, Mysuru
570001
Karnataka |
| 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 Chaithra V P |
KR hospital, Mysuru |
Department of Anaesthesia,stone building,2nd floor,Irwin road,Devraj mohala, Mysuru 57001
Mysore
KARNATAKA |
7795209749
Chaithravp.1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
| Comparator Agent |
Comparing the different doses of intravenous Dexmeditomidine infusion in attenuating haemodynamic responses to pneumoperitoneum from 5 min after creating pneumoperitoneum to till the end of pneumoperitoneum and post operative recovery in patients undergoing laparoscopic surgeries. |
Comparing different doses of intravenous Dexmeditomidine infusion (0.6mcg per kg and 0.8mcg per kg) in attenuating haemodynamic response to pneumoperitoneum from 5 min after creating pneumoperitoneum to till the end of pneumoperitoneum and post operative recovery in patients undergoing laparoscopic surgeries. |
| Intervention |
Different doses of intravenous Dexmeditomidine infusion in attenuating haemodynamic responses to pneumoperitoneum and post Operative recovery in patients undergoing laparoscopic surgeries. |
To study effect of different doses of intravenous Dexmeditomidine infusion (0.6mcg per kg and 0.8 mcg per kg) in attenuating haemodynamic responses to pneumoperitoneum from 5 min after creating pneumoperitoneum till the end of pneumoperitoneum and post operative recovery in patients undergoing laparoscopic surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All ASA grade 1 and 2 patients with BMI more than 18.5kg per meter square and less than 28kg per metre square, posted for elective laparoscopic surgery under general anaesthetia. |
|
| ExclusionCriteria |
| Details |
Patients with ischemic heart disease, uncontrolled diabetes mellitus, asthma, COPD, uncontrolled hypertension,chronic renal disease and liver diseases. Pregnant woman or lactating woman. Patients with anticipated difficulty airway. Patients with ASA grade 3 or more. |
|
|
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 |
Changes in haemodynamic parameters- Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure at intubation, during pneumoperitoneum and at extubation.
Cough reflex, shivering and sedation score post operatively. |
Changes in haemodynamic parameters- HR,SBP,DBPand MAP at baseline,at the end of Dexmeditomidine infusion,1 and 5 min after intubation,before creating pneumoperitoneum,5,15,30,45,60,90 min after creating pneumoperitoneum, at the end of pneumoperitoneum and before extubation, after extubation, 5 min and 20 min after extubation.
Cough reflex, shivering and sedation score at extubation,20 min,2 hrs and 6hrs after extubation post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS score and first rescue analgesia post operatively.
Adverse effects like Hypotension, bradycardia, PONV. |
First rescue analgesia after completion of surgery VAS more than 4
Hypotension, bradycardia, PONV at extubation, 20min, 2hr and 6hr. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/08/2025 |
| 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 - NO
|
|
Brief Summary
|
This is a Randomised Prospective comparative study to compare two different doses of Dexmeditomidine that is 0.6mcg per kg and 0.8mcg per kg intravenous as a premeditation to suppress the haemodynamic stress response to pneumoperitoneum and recovery profile in patients going elective laparoscopic surgeries under general anaesthesia.Total sample size is 90, divided into 3 groups including the control group.Primary objectives is to assess the changes in haemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure at intubation, during pneumoperitoneum and at extubation. And also Cough reflex, Shivering and sedation score post operatively.Secondary objectives includes VAS score and first rescue analgesia post operatively and adverse events like Hypotension, Bradycardia, PONV. |