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Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03640390
Enrollment
60
Registered
2018-08-21
Start date
2018-08-30
Completion date
2019-09-10
Last updated
2019-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

DRUGDexmedetomidine

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

DRUGMagnesium Sulphate

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

DRUGNormal saline

This group will receive normal saline infusion

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of analgesia24 hoursDuration of analgesia after the operation defined as the time till the first analgesic request by the patient

Secondary

MeasureTime frameDescription
Diastolic blood pressure6 hoursDiastolic blood pressure measured in mmHg
Heart rate6 hoursThe number of heart beats per minute
Onset of sensory block30 minutes after spinal anesthesiaThe time needed to have complete sensory block after spinal anesthesia measured in minutes
Systolic blood pressure6 hoursSystolic blood pressure measured in mmHg
Duration of motor block12 hoursThe time needed for recovery of motor motor after spinal anesthesia measured in hours
Ramsay Sedation Scale12 hours after spinal anesthesiaA scale used for assessment of sedation level ranges from 1 (combative) to 6 (unarousable)
Onset of motor block30 minutes after spinal anesthesiaThe time needed to have complete motor block after spinal anesthesia measured in minutes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026