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Clinical Trials/CTRI/2025/09/094890
CTRI/2025/09/094890Not yet recruitingNot Applicable

Comparative study between preemptive Ketamine and Dexmedetomidine with intravenous Paracetamol for post-operative analgesia in laparoscopic gynecological cancer surgeries: A Double-blinded randomized controlled trial.

Shubham Kumar1 site in 1 country140 target enrollmentStarted: October 1, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
140
Locations
1
Primary Endpoint
To compare the efficacy and safety of pre-emptive ketamine with Intravenous Paracetamol vs pre-emptive dexmedetomidine with Intravenous paracetamol for postoperative analgesia in patients undergoing laparoscopic gynaecological cancer surgeries.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a prospective, randomized, double-blind controlled trial designed to compare the efficacy and safety of preemptive intravenous ketamine with paracetamol versus intravenous dexmedetomedine with paracetamol for post- operative analgesia in female patients undergoing elective laparoscopic gynaecological cancer surgeries. The study will asses postoperative pain scores, total  analgesia consumption and adverse effects associated with each intervention.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Female age 18-80 years.
  • •Patients of ASA physical status 1,2 &
  • •Female Undergoing elective laparoscopic gynecological cancer surgeries.

Exclusion Criteria

  • •Patient’s refusal to participate.
  • •Patients of psychiatric disorders and unable to understand VAS and substance abuse.
  • •Drug allergy.
  • •Pregnant females.
  • •History of any underlying cardiac, hepatic, renal dysfunction.

Outcomes

Primary Outcomes

To compare the efficacy and safety of pre-emptive ketamine with Intravenous Paracetamol vs pre-emptive dexmedetomidine with Intravenous paracetamol for postoperative analgesia in patients undergoing laparoscopic gynaecological cancer surgeries.

Time Frame: Immediately after extubating, 0hr, 15min, 30min, 45min, 60min, 2hour, 4hour, 8hour,12 hour, 24hour

Secondary Outcomes

  • 1. To compare the hemodynamic stability between two groups.

Investigators

Sponsor
Shubham Kumar
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Shubham Kumar

Indira Gandhi Institute of Medical Sciences, Patna

Study Sites (1)

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