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Clinical Trials/CTRI/2024/02/062910
CTRI/2024/02/062910
Not yet recruiting
Phase 3

A comparative study of post operative analgesia using intra thecal Dexmedetomidine and fentanyl as adjuvant to bupivacaine in lower abdominal surgeries. A Randomized double blinded study

Konjengbam Reshmi Devi1 site in 1 country60 target enrollmentStarted: March 2, 2024Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Konjengbam Reshmi Devi
Enrollment
60
Locations
1
Primary Endpoint
To compare the duration of postoperative Analgesia (demand of first rescue analgesia)in first 24 hours

Overview

Brief Summary

The study will be a prospective randomized double-blinded study to assess and compare the effects of intrathecal administration of low dose of 10mg hyperbaric Bupivacaine with 5 mcg dexmedetomidine and 10 mg hyperbaric Bupivacaine with 12.5 mcg fentanyl. A total of 60 patients will be selected for the study and divided into 2 groups of 30 patients each Group A (n-30) and Group B (n-30). According to a computer-generated randomization table, patients in group A will be administered 2 ml of 0.5% bupivacaine heavy and 0.5ml (12.5µgm) fentanyl citrate and group B will be administered 2 ml of 0.5% bupivacaine heavy and 0.1 ml of 5 mcg dexmedetomidine in the subarachnoid space L3-L4. In both the groups, the study drugs will be administered at a rate of 0.2 ml/min. in the subarachnoid space L3-L4. The block characteristics along with regression of the blockade, side effects (if any) and the hemodynamic changes will be observed, assessed and recorded by blinded investigator using the VAS and sedation scale. The finding and observation made during the entire study will be tabulated graphically depicted whenever possible, statistically analysed and inference will be drawn to evaluate the duration of post-operative analgesia and side effects of the two study drugs.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

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

Inclusion Criteria

  • American Society of Anaesthesiologists (ASA) physical status I and II.
  • 18- 65 years of age.
  • Either sex.

Exclusion Criteria

  • History of allergy to study drugs
  • Bleeding disorder
  • Local site infection
  • Cardiac,respiratory and kidney disorder,neurological deficit 5.Spinal deformity.

Outcomes

Primary Outcomes

To compare the duration of postoperative Analgesia (demand of first rescue analgesia)in first 24 hours

Time Frame: Outcome will be assessed at 24 hours post-op

Secondary Outcomes

  • 1. Hemodynamic parameters- Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation (spo2)(2. Adverse effects.)

Investigators

Sponsor
Konjengbam Reshmi Devi
Sponsor Class
Other [[self]]
Responsible Party
Principal Investigator
Principal Investigator

Konjengbam Reshmi Devi

Regional Institute of Medical Sciences, Imphal

Study Sites (1)

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