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NCT Number: NCT03640390

Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

Magnesium sulphate

Drug

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

normal saline

Drug

This group will receive normal saline infusion

Primary outcomes

  1. Duration of analgesia

    Time frame: 24 hours

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

Secondary outcomes

  1. Systolic blood pressure

    Time frame: 6 hours

    Systolic blood pressure measured in mmHg

  2. Diastolic blood pressure

    Time frame: 6 hours

    Diastolic blood pressure measured in mmHg

  3. Heart rate

    Time frame: 6 hours

    The number of heart beats per minute

  4. Onset of sensory block

    Time frame: 30 minutes after spinal anesthesia

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

  5. Onset of motor block

    Time frame: 30 minutes after spinal anesthesia

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

  6. Duration of motor block

    Time frame: 12 hours

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

  7. Ramsay Sedation Scale

    Time frame: 12 hours after spinal anesthesia

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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