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Clinical Trials/CTRI/2023/04/051958
CTRI/2023/04/051958Not yet recruitingNot Applicable

A randomized comparative control study on effects of dexmedetomidine versus dexamethasone on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic surgery under general anaesthesia.

Suchana Maji1 site in 1 country105 target enrollmentStarted: August 5, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
105
Locations
1
Primary Endpoint
To evaluate and compare complete response to and/or incidence of Post operative nausea and vomiting with dexmedetomidine and dexamethasone seperately.

Study Overview

Brief Summary

This study is a randomized,double blinded, parallel group, single centre trial evaluating and comparing the efficacy of intravenous dexmethasone and intravenous dexmedetomidine on incidence of post opearative nausea and vomiting in patients undergoing laproscopic surgeries under general anaesthesia. the primary outcome will be to evaluate and compare complete response to and/or incidence of Post operative nausea and vomiting with dexmedetomidine and dexamethasone seperately. secondary outcomes will be to compare and evaluate incidence of rescue antiemetic used with dexmedetomidine and dexamethasone,to compare and evaluate side effects of dexmedetomidine and dexamethasone,to compare and evaluate patient satisfaction with Post-opeartive Nausea and vomiting.

Study Design

Study Type
Interventional
Allocation
Random Number Table
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients of ASA physical status I and II, both gender in the mentioned age group who will give written informed consent.

Exclusion Criteria

  • •Patients with ASA physical status III of greater.
  • •Severe cardiorespiratory,hepatic,renal,neurological or endocrinal disease.
  • •Bradycardia(Heart Rate<60bpm).
  • •Pregnant and lactating women.
  • •Obesity(BMI>30kg/m2).
  • •Diabetes mellitus.
  • •Patientswith known hypersensivity of drug allergies.
  • •Patients who had taken H2 antagonists,antiemetic or psychoactive medication.
  • •Nausea, retching,or vomiting within 48hours before surgery.
  • •History of Motion sickness.
  • •Patients who refuse to participate in the study.

Outcomes

Primary Outcomes

To evaluate and compare complete response to and/or incidence of Post operative nausea and vomiting with dexmedetomidine and dexamethasone seperately.

Time Frame: Baseline | Before Administration Of Drug | After administration of Drug | During Intubation | After Intubation | 45 mins Intraoperatively | At the end of Surgery | 15 minutes postoperatively | 2 hours postoperatively | 6 hours postoperatively | 12 hours postoperatively

Secondary Outcomes

  • To compare and evaluate incidence of rescue antiemetic used with dexmedetomidine and dexamethasone.(To compare and evaluate side effects of dexmedetomidine and dexamethasone.)

Investigators

Sponsor
Suchana Maji
Sponsor Class
Other [self]

Study Sites (1)

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