Effects of Intrathecal Dexmedetomidine as an Adjuvant to Low Dose Hyperbaric 0.5% Bupivacaine

NCT05993975 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: SAbbas
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be enrolled in one of the two groups using a computer-generated random number table: Group I will receive 1.5 ml of 0.5% hyperbaric bupivacaine (7.5 mg). Group II will receive 1.2 mL of 0.5% hyperbaric bupivacaine (6 mg) along with 0.3 mL (3 μg )of dexmedetomidine (total 1.5 mL).

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (5)

• Height of sensory block

  Dermatome level having absence of cold sensation

  0 to 4 hours

• Motor block

  According to Bromage scores Grade Criteria I Free movement of legs and feet II Just able to flex knees with free movement of feet III Unable to flex knees, but with free movement of feet IV Unable to move legs or feet we need paralysis of both legs (Bromage score IV) for surgery

  0 to 4 hours

• Time for 2 segment regression of sensory block

  Dermatome level having absence of cold sensation

  0 to 4 hours

• Heart rate

  By anaesthesia ECG monitor

  0 to 4 hours

• Mean Blood pressure

  Non invasive blood pressure monitoring devise

  0 to 4 hours

Secondary Outcomes (1)

• Shivering

  0 to 4 hours

Study Arms (2)

BUPIPURE

ACTIVE COMPARATOR

Hyperbaric Bupivacaine 0.5% (1.5 ml/7.5 mg) to be given intrathecally Total volume 1.5 mL

Drug: Bupivacain 0.5%

BUPI-DEX

EXPERIMENTAL

Hyperbaric Bupivacaine 0.5% (1.2 ml/6 mg)+Dexmedetomidine (0.3 mL) 3 microgram intrathecally. Total volume 1.5 mL

Drug: Bupivacain 0.5%; Drug: Dexmedetomidine Hydrochloride

Interventions

Bupivacain 0.5% DRUG

Bupivacaine hydrochloride was given without any adjuvant

Also known as: Pure Bupivacain 0.5%

BUPI-DEX; BUPIPURE

Dexmedetomidine Hydrochloride DRUG

Use of Dexmedetomidine Hydrochloride 5 micrograms (1 mL) as an adjuvant with bupivacaine hydrochloride

Also known as: Dexmedetomidine 5 microgram

BUPI-DEX

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: Male patients coming for transurethral resection of the prostate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I to ASA II
• Age 50 to 80 years old
• Height between 155cm and 175 cm

You may not qualify if:

• History of spine surgery or the presence of an infectious focus on the back
• Patient's refusal to undergo a spinal anaesthesia
• Hypersensitivity to bupivacaine or dexmedetomidine
• Patients taking drugs of abuse or narcotic analgesics
• Diabetic neuropathy
• History of bleeding disorders
• Oral/intravenous anticoagulant therapy
• History of arrhythmias or labile hypertension
• Unco-operative patients
• Hearing defect
• ASA III and IV
• Central or peripheral nervous system disorders
• Severe hypovolemia

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Syed Muhammad Abbas

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ali A Lanewala, MD, PhD

  Sindh Institute of Urology & Transplantation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anaesthesia

Model Details: Group BUPPURE will receive 1.5 ml of hyperbaric 0.5% bupivacaine (1.5 ml/7.5 mg) whereas the BUPIDEX group will receive Dexmedetomidine 3 micrograms (0.3mL)with hyperbaric 0.5% bupivacaine (1.2 ml/6 mg) to be given to one group.

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: August 16, 2023
• Study Start: July 20, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)