Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

NCT ID: NCT03640390

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2019-09-10

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Dexmedetomidine group

This group will receive dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

This group will receive Dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour.

Magnesium Sulphate group

This group will receive Magnesium Sulphate infusion at a rate of 15 mg/Kg/hour

Group Type: ACTIVE_COMPARATOR

Magnesium Sulphate

Intervention Type: DRUG

This group will receive Magnesium sulphate infusion at a rate of 15 mg/Kg/hour

Saline group

This group will receive normal saline infusion

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

This group will receive normal saline infusion

Interventions

Dexmedetomidine

This group will receive Dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour.

Intervention Type: DRUG

Magnesium Sulphate

This group will receive Magnesium sulphate infusion at a rate of 15 mg/Kg/hour

Intervention Type: DRUG

Normal saline

This group will receive normal saline infusion

Intervention Type: DRUG

Other Intervention Names

Precedex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hasanin

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inas Farouk, Lecturer

Role: STUDY_DIRECTOR

Lecturer of anesthesia

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-112-2017

Identifier Type: -

Identifier Source: org_study_id