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Clinical Trials/CTRI/2024/06/068928
CTRI/2024/06/068928
Not yet recruiting
Phase 4

Comparative efficacy of intravenous dexmedetomidine and intravenous dexamethasone on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological laparoscopic surgery

Vardhman Mahavir Medical College and Safdarjung Hospital1 site in 1 country84 target enrollmentStarted: August 15, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Vardhman Mahavir Medical College and Safdarjung Hospital
Enrollment
84
Locations
1
Primary Endpoint
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

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Patients of age 18-65 years with American society of Anesthesiologist I and II undergoing gynaecological laparoscopic surgery.

Exclusion Criteria

  • 1.patients with a known history of Gastric esophageal Reflux Disease 2.Allergic to study drugs 3.Body mass index ≥30kg/m2.

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
Vardhman Mahavir Medical College and Safdarjung Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Gnanavel R

Vardhman Mahavir Medical College and Safdarjung Hospital

Study Sites (1)

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