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Not yet recruiting NCT06662175

Role of Dexmedetomidine as Synergistic Agent

Phase II / Phase III Interventional Dexmedetomidine Hyperbaric Bupivacaine Subarachnoid Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperbaric bupivacaine, hyperbaric bupivacaine and dexmedetomidine.
Who it may be relevant to
Registry conditions: Dexmedetomidine, Hyperbaric Bupivacaine, Subarachnoid Anesthesia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Drug Hyperbaric bupivacaine
    Group A (Unexposed) will received 2 ml of intrathecal bupivacaine
  • Drug hyperbaric bupivacaine and dexmedetomidine
    Group B (Exposed) will receive a combination of bupivacaine and Dexmedetomidine infusion

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Investigate the safety profile of Dexmedetomidine in combination with hyperbaric bupivacaine, in term of adverse events such as hypotension, bradycardia, and patient satisfaction. [Time frame: till the shifting of patient to parent ward.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Lady Reading Hospital Mti Peshawar Kp Pakistan — Peshawar

Publications

  • 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

Identifiers

NCT: NCT06662175 · 359/LRH/MTI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗