Role of Dexmedetomidine as Synergistic Agent

NCT06662175 | Not Yet Recruiting Phase 2

• 1 other identifier: 359/LRH/MTI
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to contribute valuable insights into the role of Dexmedetomidine as a synergistic agent in prolonging subarachnoid block duration, with the overarching goal of enhancing perioperative care and surgical success rates.

Conditions

Dexmedetomidine; Hyperbaric Bupivacaine; Subarachnoid Anesthesia

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of Dexmedetomidine when used adjunctively with hyperbaric bupivacaine in extending the duration of sensory and motor blockade in subarachnoid anesthesia.

  Sensory Blockade Duration: This refers to the time interval from the administration of the subarachnoid block until the complete recovery of sensory function in the dermatomes affected by the anesthesia. It will be assessed using standardized sensory tests, such as pinprick or cold sensation, within the affected dermatomes. Motor Blockade Duration:It encompasses the time from the onset of motor blockade to the complete recovery of motor function and will assessed by evaluating muscle strength and movement capability using modified Bromage score as 0=Subject is able to lift the leg straight and move the hip, knee and ankle. 1. Subject is unable to lift the leg straight but is able to lift the leg straight but is able to flex the knee and ankle freely. 2. Subject is unable to flex the knee and hip, but is able to flex the ankle. 3. Subject is unable to flex the ankle, knee, and hip, but is able to move toes. 4. No movement in the lower extremity.

  periodically motor blockade will be assessed until the achievement of modified Bromage score 3 from giving anesthesia till shifting of the patient to parent ward

Secondary Outcomes (1)

• Investigate the safety profile of Dexmedetomidine in combination with hyperbaric bupivacaine, in term of adverse events such as hypotension, bradycardia, and patient satisfaction.

  till the shifting of patient to parent ward.

Study Arms (2)

Group A Hyperbaric Bupivicaine

EXPERIMENTAL

Group A (Unexposed) will received 2 ml of intrathecal bupivacaine.

Drug: Hyperbaric bupivacaine

GROUP B Hyperbaric Bupivacaine and Dexmedetomidine

EXPERIMENTAL

Group B (Exposed) will receive a combination of bupivacaine and Dexmedetomidine infusion.

Drug: hyperbaric bupivacaine and dexmedetomidine

Interventions

Hyperbaric bupivacaine DRUG

Group A (Unexposed) will received 2 ml of intrathecal bupivacaine

Group A Hyperbaric Bupivicaine

hyperbaric bupivacaine and dexmedetomidine DRUG

Group B (Exposed) will receive a combination of bupivacaine and Dexmedetomidine infusion

GROUP B Hyperbaric Bupivacaine and Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either gender aged between 18 and 65 years.
• Patients scheduled for surgical procedures of lower limb requiring subarachnoid anesthesia.
• American Society of Anesthesiologists (ASA) physical status classification I or II.

You may not qualify if:

• Patients with contraindications to subarachnoid anesthesia, including severe coagulopathy, infection at the site of injection, or increased intracranial pressure.
• Patients with a history of significant cardiac, respiratory, hepatic, or renal disease.
• Pregnant or lactating women.
• Patients with a history of substance abuse or dependence.
• Patients on chronic opioid therapy or with opioid tolerance.
• Patients with neurological deficits affecting sensation or motor function in the lower extremities.
• Patients with psychiatric disorders affecting their ability to cooperate during the procedure or follow instructions.

Sponsors & Collaborators

• Lady Reading Hospital, Pakistan: lead

Study Sites (1)

Lady Reading Hospital Mti Peshawar Kp Pakistan

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (1)

• Sharma A, Varghese N, Venkateswaran R. Effect of intrathecal dexmedetomidine versus intravenous dexmedetomidine on subarachnoid anesthesia with hyperbaric bupivacaine. J Anaesthesiol Clin Pharmacol. 2020 Jul-Sep;36(3):381-385. doi: 10.4103/joacp.JOACP_323_17. Epub 2020 Sep 14.

  PMID: 33487907 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

FARYAL UZMA, MBBS

CONTACT

+923315138986; faryaluzma1606@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faryal Uzma Prinicipal Investigator

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: November 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)