Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia for Lower Abdominal Surgery

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Magnesium Sulphate; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine group; This group will receive dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour	Drug: Dexmedetomidine; This group will receive Dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour.; Other Names: Precedex
Active Comparator: Magnesium Sulphate group; This group will receive Magnesium Sulphate infusion at a rate of 15 mg/Kg/hour	Drug: Magnesium Sulphate; This group will receive Magnesium sulphate infusion at a rate of 15 mg/Kg/hour
Placebo Comparator: Saline group; This group will receive normal saline infusion	Drug: Normal saline; This group will receive normal saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	Duration of analgesia after the operation defined as the time till the first analgesic request by the patient	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Systolic blood pressure measured in mmHg	6 hours
Diastolic blood pressure	Diastolic blood pressure measured in mmHg	6 hours
Heart rate	The number of heart beats per minute	6 hours
Onset of sensory block	The time needed to have complete sensory block after spinal anesthesia measured in minutes	30 minutes after spinal anesthesia
Onset of motor block	The time needed to have complete motor block after spinal anesthesia measured in minutes	30 minutes after spinal anesthesia
Duration of motor block	The time needed for recovery of motor motor after spinal anesthesia measured in hours	12 hours
Ramsay Sedation Scale	A scale used for assessment of sedation level ranges from 1 (combative) to 6 (unarousable)	12 hours after spinal anesthesia

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Inas Farouk, Lecturer, Lecturer of anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): September 10, 2019

Study Registration Dates

• First Submitted: August 18, 2018
• First Submitted That Met QC Criteria: August 18, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Dexmedetomidine; Magnesium Sulfate
• Other Study ID Numbers: N-112-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No