| CTRI Number |
CTRI/2023/08/057149 [Registered on: 31/08/2023] 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
|
Postoperative nausea, vomiting and hemodynamic changes (heart rate and blood pressure) in gynecological laparoscopic surgery without use of opioid |
|
Scientific Title of Study
|
Comparison of opioid free anesthesia on postoperative nausea,vomiting and haemodynamic changes after gynaecological laproscopy |
| 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 KANCHAN BANCHHOR |
| Designation |
DNB Student |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Anesthesia, Second floor, OT Complex, Apollo Hospitals Bilaspur, Seepat Road, Lingiadih village
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9340518257 |
| Fax |
|
| Email |
kanchan170995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Anesthesia, Second floor, OT Complex, Apollo Hospitals Bilaspur, Seepat Road, Lingiadih village
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 |
Department of Anesthesia, Second floor OT Complex, Apollo Hospitals Bilaspur, Seepat Road, Lingiadih village
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospital Bilaspur, Seepat road Lingiadih Village |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Bilaspur |
| Address |
Seepat road Lingiadih village, Bilaspur Chhattisgarh |
| 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 KANCHAN BANCHHOR |
Apollo Hospitals Bilaspur |
OT Complex Second floor Seepat Road
Bilaspur
CHHATTISGARH |
9340518257
kanchan170995@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 |
dexmedetomidine loading dose 1 mcg/kg over 15 mins duration, 5 mins before induction then 0.5 mcg/kg/hr maintenance dose throughout the surgery |
| Intervention |
Fentanyl |
Fentanyl 1.5 mcg/kg 5 mins before induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA grade I and II
2. Scheduled for laparoscopic gynecological surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
1.Known allergy to study drugs
2.Use of antiemetic drugs within 24 hrs of surgery
3.Morbid obesity(BMI>40)
4.Chronic use of opioids
5.Patients with hepatic,renal or cardiovascular dysfunction
6.Psychiatric patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative nausea & vomiting |
24 hour postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic changes heart rate systolic blood pressure diastolic blood pressure mean blood pressure |
Preoperative period, after study drug, after induction, after intubation, after pneumoperitoneum at 15 min intervals, post pneumoperitoneum, after surgery, after extubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| Date of Study Completion (India) |
30/12/2024 |
| 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 distressing complaints after general anesthesia in laparoscopic surgery. PONV incidence as high as 60-80% in high risk patients with use of opioids in gynecological laparoscopic surgery. So avoidance of opioids and use of other drugs like dexmedetomidine is another alternative for intraoperative maintenance of anesthesia. Intraoperative hemodynamic changes are also important by use dexmedetomidine in place of opioids. So we designed a study to compare the effectiveness of fentanyl and dexmedetomidine for prevention of postoperative nausea and vomiting and comparison of intraoperative hemodynamic changes (heart rate and blood pressure). All selected patients will be randomized in to two groups (40 patients in each group) depending on the drug given.
Group A - received fentanyl 1.5 mcg/kg, 5 mins before induction of anesthesia
Group B - received dexmedetomidine loading dose 1 mcg/kg over 15 min duration, 5 mins before induction then 0.5 mcg/kg/hr maintenance dose throughout the surgery.
Primary out come - postoperative nausea and vomiting in first 24 hrs postoperative period Secondary outcome - hemodynamic changes at various intraoperative intervals
Statistical analysis will be done after completion of study. |