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Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

Phase 3
Completed
Conditions
Postoperative Pain
Interventions
Registration Number
NCT03640390
Lead Sponsor
Cairo University
Brief Summary

The aim of this work is to compare the hemodynamic and analgesic properties of Dexmedetomidine and Magnesium sulphate infusion in lower abdominal surgery.

Detailed Description

Dexmedetomidine is a relatively new alpha 2 adrenergic receptor agonist with a higher α2/α1 selectivity ratio of 1620:1 that provides analgesic and anesthetic effects . Dexmedetomidine has various clinical uses in anesthesia such as sedation, and prolongation of the duration of postoperative analgesia when used as an adjuvant through intrathecal, epidural, or intravenous routes.

Magnesium sulphate is another commonly used drug in anesthesia. Magnesium sulphate suppresses nociceptive impulses through inhibition of voltage-gated calcium channels and through antagonism of the N-methyl D-aspartate (NMDA) receptors.

Although both drugs were reported to prolong the duration of spinal anesthesia, no studies to the best of our knowledge had compared the analgesic and hemodynamic profile of both drugs when used as intravenously during spinal anesthesia.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Adult patients aged between 18 and 65 years.
  • Scheduled for lower abdominal surgery.
Exclusion Criteria
  • Systolic blood pressure less than 100 mmHg
  • Coagulation disorders
  • History of heart failure
  • Mitral or Aortic stenosis

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Saline groupNormal salineThis group will receive normal saline infusion
Magnesium Sulphate groupMagnesium SulphateThis group will receive Magnesium Sulphate infusion at a rate of 15 mg/Kg/hour
Dexmedetomidine groupDexmedetomidineThis group will receive dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour
Primary Outcome Measures
NameTimeMethod
Duration of analgesia24 hours

Duration of analgesia after the operation defined as the time till the first analgesic request by the patient

Secondary Outcome Measures
NameTimeMethod
Systolic blood pressure6 hours

Systolic blood pressure measured in mmHg

Heart rate6 hours

The number of heart beats per minute

Duration of motor block12 hours

The time needed for recovery of motor motor after spinal anesthesia measured in hours

Diastolic blood pressure6 hours

Diastolic blood pressure measured in mmHg

Onset of sensory block30 minutes after spinal anesthesia

The time needed to have complete sensory block after spinal anesthesia measured in minutes

Onset of motor block30 minutes after spinal anesthesia

The time needed to have complete motor block after spinal anesthesia measured in minutes

Ramsay Sedation Scale12 hours after spinal anesthesia

A scale used for assessment of sedation level ranges from 1 (combative) to 6 (unarousable)

Trial Locations

Locations (1)

Cairo University

🇪🇬

Cairo, Egypt

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