| CTRI Number |
CTRI/2019/08/020888 [Registered on: 26/08/2019] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Prevention of postoperative nausea and vomiting and reduction of analgesic requirement by use of dexamethasone, dexmedetomidine and combination of dexamethasone-dexmedetomidine. |
|
Scientific Title of Study
|
Comparision of intraperitoneal dexamethasone, dexmedetomidine and dexamethasone-dexmedetomidine combination on postoperative nausea and vomiting and analgesics requirement after gynecological laparoscopy: a randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Second floor, OT complex, Department of Anesthesia, Apollo Hospitals Bilaspur, Seepat road, Lingiadih village
Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Shree |
| Designation |
DNB Student |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Anesthesia Apollo Hospitals Bilaspur
Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
|
| Fax |
|
| Email |
poojasgupta125@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, Department of Anesthesia, Apollo Hospitals Bilaspur,
Seepat Road, Lingiadih village
Bilaspur
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 |
lingiadih village Seepat road
Biaspur |
| 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 Vinit Kumar Srivastava |
Apollo Hospitals Bilaspur |
Department of
Anesthesia, Second
Floor, O T Complex
Bilaspur
Bilaspur
CHHATTISGARH |
9755557539
drvinit75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Apollo Hospitals Bilaspur (CG) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
Dexamethasone 8 mg through intraperitoneal route at the end of the procedure, before laparoscopic trocar withdrawal, in total volume of 20 ml |
| Intervention |
Dexamethasone-dexmedetomidine |
Dexamethasone 8 mg + dexmedetomidine1 μg/kg combination through intraperitoneal route at the end of the procedure, before laparoscopic trocar withdrawal (diluted in 20 ml) |
| Intervention |
Dexmedetomidine |
Dexmedetomidine1 μg/kg through intraperitoneal route at the end of the procedure, before laparoscopic trocar withdrawal (diluted in 20 ml NS) |
| Comparator Agent |
Normal saline |
Normal saline 20 ml through intraperitoneal route at the end of the procedure, before laparoscopic trocar withdrawal.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA grade I and II
2. Scheduled for laparoscopic gynaecological surgery under general anesthesia
|
|
| ExclusionCriteria |
| Details |
1.Known allergy to study drugs
2.Use of antiemetic drugs within 24 hours of surgery
3.Morbid obesity( body mass index>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 |
| Incidence of post operative nausea and vomiting |
24 hr postoperatve period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total consumption of paracetamol |
24 hr postoperative period |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/09/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Srivastava VK, Shree P, Agarwal S, Pandey A, Babbar K, Kumari M. Comparison of intraperitoneal dexamethasone, dexmedetomidine and dexamethasone-dexmedetomidine combination on postoperative nausea, vomiting and analgesics requirement after gynaecological laparoscopy: A randomised clinical trial. Bali J Anaesthesiology. 2022;6(4):225-30. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Postoperative nausea and vomiting is common, but distressing complaint following general anesthesia. The PONV incidence as high as 60% to 80% in high risk patients when no prophylactic antiemetics used. In this modern era of surgery intraperitoneal instillation of drugs has become an important method to control postoperative nausea and vomiting and decrease the analgesic requirement. Intraperitoneal dexamethasone and dexmedetomidine has been used separately for prevention of PONV. However, there is no study to compare the effectiveness of these drugs alone or in combination for prevention of PONV and analgesic requirement via intraperitoneal route. All selected patients will be randomized in to 4 groups (40 in each group) depending on the drug given Group D1 - received dexamethasone 8 mg intraperitoneally at the end of the procedure, before laparoscopic trocar withdrawal, in total volume of 20 ml Group D2 - received dexmedetomidine 1 mcg/kg intraperitoneally at same time and same volume Group D3 - received dexamethasone 8 mg and dexmedetomidine 1 mcg/kg at the same time and same volume Group D4 - receive 20 ml normal saline at the same time
Primary outcome - incidence of post operative nausea and vomiting Secondary outcome - Total paracetamol requirement in 24 hr post operative period
Statistical analysis will be done after completion of study |