| CTRI Number |
CTRI/2024/06/068928 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
To Comparing the effectiveness of intravenous Dexmedetomidine and intravenous dexamethasone for the prevention of nausea and vomiting in postoperative period in patients undergoing gynaecological laparoscopic surgery |
|
Scientific Title of Study
|
Comparative efficacy of intravenous dexmedetomidine and intravenous dexamethasone on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological laparoscopic surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gnanavel R |
| Designation |
Post Graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesiology and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9952152160 |
| Fax |
|
| Email |
devarajgnanavel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesiology and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesiology and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi ,pin code -110029, INDIA |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, ,new delhi,pin code -110029, INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 Gnanavel R |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anesthesiology and intensive care, Ground floor,Main OT Block, Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
DELHI |
9952152160
devarajgnanavel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N888||Other specified noninflammatory disorders of cervix uteri, (2) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, (3) ICD-10 Condition: N739||Female pelvic inflammatory disease, unspecified, (4) ICD-10 Condition: N809||Endometriosis, unspecified, (5) ICD-10 Condition: N839||Noninflammatory disorder of ovary,fallopian tube and broad ligament, unspecified, (6) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
Patient undergoing gynaecological laparoscopic surgery will be given single dose of intravenous dexamethasone 8 mg bolus before induction and will be assessed for postoperative nausea and vomiting at 0 hr,4 hrs ,8 hrs,12 hrs |
| Intervention |
Dexmedetomidine |
Patient undergoing gynaecological laparoscopic surgery will be given single dose of intravenous dexmedetomidine (1mcg/kg) bolus before induction and will be assessed for postoperative nausea and vomiting at 0 hr,4 hrs,8 hrs,12hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients of age 18-65 years with American society of Anesthesiologist I and II undergoing gynaecological laparoscopic surgery. |
|
| ExclusionCriteria |
| Details |
1.patients with a known history of Gastric esophageal Reflux Disease
2.Allergic to study drugs
3.Body mass index ≥30kg/m2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative nausea and vomiting score using visual analog scale at 8 hrs after administration of dexmedetomidine and dexamethasone in patients undergoing gynaecological laparoscopic surgeries |
To compare the postoperative nausea and vomiting score using visual analog scale at 8 hrs after administration of dexmedetomidine and dexamethasone in patients undergoing gynaecological laparoscopic surgeries |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative nausea and vomiting score using visual analog scale |
0 hr, 4 hrs,12hrs |
| Intraoperative hemodynamic parameter |
Intraoperatively every 5 mins vital parameters will be assessed |
| Sedation score |
Postoperatively using Ramsay sedation score |
| Postoperative pain |
Postoperatively using visual analog scale |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
15/08/2024 |
| 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="6"
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 undertaken to compare the efficacy of dexmedetomidine and dexamethasone for the prevention of postoperative nausea and vomiting in patients undergoing gynaecological laparoscopic surgery.primarily Postoperative nausea and vomiting score will be recorded and secondarily intraoperative hemodynamic parameters , sedation score and postoperative pain using visual analog scale will be assessed. |