Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640390
• Other study ID #: N-112-2017
• Status: Completed
• Phase: Phase 3
• Start date: August 30, 2018
• Est. completion date: September 10, 2019

Study information

• Verified date: November 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 10, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexmedetomidine
This group will receive Dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour.
• Magnesium Sulphate
This group will receive Magnesium sulphate infusion at a rate of 15 mg/Kg/hour
• Normal saline
This group will receive normal saline infusion

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of analgesia	Duration of analgesia after the operation defined as the time till the first analgesic request by the patient	24 hours
Secondary	Systolic blood pressure	Systolic blood pressure measured in mmHg	6 hours
Secondary	Diastolic blood pressure	Diastolic blood pressure measured in mmHg	6 hours
Secondary	Heart rate	The number of heart beats per minute	6 hours
Secondary	Onset of sensory block	The time needed to have complete sensory block after spinal anesthesia measured in minutes	30 minutes after spinal anesthesia
Secondary	Onset of motor block	The time needed to have complete motor block after spinal anesthesia measured in minutes	30 minutes after spinal anesthesia
Secondary	Duration of motor block	The time needed for recovery of motor motor after spinal anesthesia measured in hours	12 hours
Secondary	Ramsay Sedation Scale	A scale used for assessment of sedation level ranges from 1 (combative) to 6 (unarousable)	12 hours after spinal anesthesia