| CTRI Number |
CTRI/2023/08/057104 [Registered on: 30/08/2023] Trial Registered Prospectively |
| Last Modified On: |
08/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Inhalation anesthesia with sevoflurane vs intravenous anesthesia with propofol and dexmedetomidine on postoperative nausea vomiting and recovery parameters after anesthesia |
|
Scientific Title of Study
|
Comparison of inhalational anesthesia (Sevoflurane) and total intravenous anesthesia with propofol, dexmedetomidine on postoperative nausea and vomiting and postoperative recovery parameters in laparoscopic surgery - A prospective randomized controlled 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. Gunjan Yadav |
| Designation |
DNB Student |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Anesthesia, Second floor, OT Complex, Apollo Hospitals Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
7999980678 |
| Fax |
|
| Email |
gunjanyadav2804@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Second floor OT Complex Apollo Hospitals Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Second floor OT Complex Apollo Hospitals Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals Bilaspur, Seepat Road, Lingiadih village, Bilaspur |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Bilaspur |
| Address |
Seepat Road Lingiadih Village, Bilaspur |
| 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 Gunjan Yadav |
Apollo Hospitals Bilaspur |
Second Floor OT Complex Seepat Road
Bilaspur
CHHATTISGARH |
7999980678
gunjanyadav2804@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Apollo Hospitals Bilaspur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N838||Other noninflammatory disorders ofovary, fallopian tube and broad ligament, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine and Propofol |
Bolus dose of Dexmedetomidine 1 mcg/kg over 15 min before induction of anesthesia. Maintenance of anesthesia with dexmedetomidine (0.5mcg/kg/hr) and titrated dose of propofol (50 to 100 mcg/kg/min) |
| Intervention |
Sevoflurane |
During intraoperative maintenance of anesthesia (1% to 3%) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade I and II
Scheduled for laparoscopic surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
1. Known allergy to study drug.
2. Use of antiemetic drug within 24 hour of surgery.
3. Morbid obesity (BMI >40)
4. Chronic use of opioids.
5. Patient with hepatic , renal and cardiovascular dysfunction.
6. Psychiatric patients.
7. Patient with history of motion sickness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative nausea & vomiting |
24 hour postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Extubation time (minute)
2. Respond to verbal command (minute)
3. Orientation time (minute)
|
Postoperative period |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/09/2023 |
| Date of Study Completion (India) |
15/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Postoperative nausea and vomiting are common and problematic after general anesthesia in laparoscopic surgery. its incidence as high as 60-80% in high risk patients. Use of opioids and volatile anesthetic agents during maintenance of anesthesia increase the incidence of postoperative nausea and vomiting. So use of alternative agents like propofol and dexmedetomidine during maintenance of anesthesia is effective for prevention of postoperative nausea and vomiting. Postoperative parameters are also variable by using of two different methods during maintenance of anesthesia. So we designed a study to compare the effectiveness of inhalational (sevoflurane) and total intravenous anesthesia with propofol and dexmedetomidine for reduction of postoperative nausea and vomiting and variability in postoperative recovery parameters. All selected patients will be randomized in to two groups (40 patients in each group) depending on the agents used during maintenance of anesthesia. Induction of anesthesia is similar in both groups.
Group A - Anesthesia will be maintained with O2:N2O; 40:60 and sevoflurane to achieve a target BIS between 40 to 60.
Group B- Dexmedetomidine loading dose 1mcg/kg over 15 minutes duration, 5 minutes before induction of anesthesia. Anesthesia will be maintained with dexmedetomidine 0.5mcg/kg/hr and titrated dose of propofol to achieve a target BIS between 40 to 60.
Primary outcome - postoperative nausea and vomiting in first 24 hour postoperative period Secondary outcome - Postoperative recovery parameter (extubation time, respond to verbal command and orientation time in minutes)
Statistical analysis will be done after completion of study. |