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Clinical Trials/NCT06662175
NCT06662175
Not yet recruiting
Phase 2

Role of Dexmedetomidine as Synergistic Agent to Prolong a Subarachnoid Block Duration

Lady Reading Hospital, Pakistan1 site in 1 country166 target enrollmentNovember 2024

Overview

Phase
Phase 2
Intervention
Hyperbaric bupivacaine
Conditions
Dexmedetomidine
Sponsor
Lady Reading Hospital, Pakistan
Enrollment
166
Locations
1
Primary Endpoint
Evaluate the efficacy of Dexmedetomidine when used adjunctively with hyperbaric bupivacaine in extending the duration of sensory and motor blockade in subarachnoid anesthesia.
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Detailed Description

Dexmedetomidine is a frequently used alpha-2 adrenergic agonist for anesthesia and sedation due to its excellent selectivity. Dexmedetomidine can cause drowsiness, analgesia, and sympathetic reactions when injected intravenously. Dexmedetomidine has been investigated for possible synergistic benefits when used in conjunction with hyperbaric bupivacaine for subarachnoid block, sometimes referred to as spinal anesthesia. Because hyperbaric bupivacaine can produce a rapid onset and a longer duration of sensory and motor blockage, it is a common local anesthetic used in spinal anesthesia. Numerous research studies have examined the synergistic effects of intravenous dexmedetomidine and hyperbaric bupivacaine in subarachnoid blocks. These effects are primarily observed in terms of extending the duration of sensory and motor blockade, enhancing postoperative analgesia, decreasing intraoperative and postoperative opioid consumption, and improving patient satisfaction. The mechanism underlying this synergistic effect is believed to be connected to the effects of dexmedetomidine on the central nervous system, which include its capacity to modify pain pathways, improve spinal anesthesia, and produce drowsiness and anxiolysis. Although the combination of dexmedetomidine with hyperbaric bupivacaine has demonstrated encouraging outcomes in a number of studies, there is still discussion and continuing research over the best time, dosage, and patient selection criteria. As with any anesthesia procedure, the best course of action should be determined after taking into account specific patient considerations such age, comorbidities, and concurrent drugs. Hameed et al compare the Synergistic effect of Dexmedetomidine on Subarachnoid Block with Hyperbaric Bupivacaine among three groups. In there study Patients in Group 1 received 2 ml of intrathecal bupivacaine; Group 2 received a combination of bupivacaine and Dexmedetomidine infusion; and Group 3 received bupivacaine followed by Dexmedetomidine infusion. Their study show that onset time of sensory blockade. The duration of sensory blockade and the rate of recovery of complete sensory block was significantly higher in Group 2 compared to Group 1. The distribution of adverse effect among group 1 and group 2 was, hypotension 20% vs 40%, Bradycadria 8% vs 24%, and Nausea 12% vs 12% respectively. Previous studies have indicated that Dexmedetomidine can enhance the duration and quality of sensory blockade, improve postoperative analgesia, and reduce opioid consumption when used in conjunction with hyperbaric bupivacaine. Despite these promising findings, further exploration is warranted to elucidate the optimal dosage, timing, and patient selection criteria for Dexmedetomidine administration in subarachnoid blocks. Understanding the mechanistic basis of Dexmedetomidine's synergistic effects on subarachnoid block duration is crucial for refining anesthesia protocols and ultimately improving patient outcomes. By conducting this research study, the investigators aim 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.

Registry
clinicaltrials.gov
Start Date
November 2024
End Date
September 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lady Reading Hospital, Pakistan
Responsible Party
Principal Investigator
Principal Investigator

Faryal Uzma

Faryal Uzma Prinicipal Investigator

Lady Reading Hospital, Pakistan

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

Group A Hyperbaric Bupivicaine

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

Intervention: Hyperbaric bupivacaine

GROUP B Hyperbaric Bupivacaine and Dexmedetomidine

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

Intervention: hyperbaric bupivacaine and dexmedetomidine

Outcomes

Primary Outcomes

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

Time Frame: 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

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.

Secondary Outcomes

  • 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 Sites (1)

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