Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Normal saline; Drug: Dexmedetomidine; Drug: Magnesium Sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT03640390

N-112-2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Magnesium Sulphate group

Active Comparator group

Description:

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

Treatment:

Drug: Magnesium Sulphate

Saline group

Placebo Comparator group

Description:

This group will receive normal saline infusion

Treatment:

Drug: Normal saline