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Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Magnesium Sulphate
Normal saline
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine group

Magnesium Sulphate group

Saline group

Arm Description

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

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

This group will receive normal saline infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Systolic blood pressure
Systolic blood pressure measured in mmHg
Diastolic blood pressure
Diastolic blood pressure measured in mmHg
Heart rate
The number of heart beats per minute
Onset of sensory block
The time needed to have complete sensory block after spinal anesthesia measured in minutes
Onset of motor block
The time needed to have complete motor block after spinal anesthesia measured in minutes
Duration of motor block
The time needed for recovery of motor motor after spinal anesthesia measured in hours
Ramsay Sedation Scale
A scale used for assessment of sedation level ranges from 1 (combative) to 6 (unarousable)

Full Information

First Posted
August 18, 2018
Last Updated
November 13, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03640390
Brief Title
Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia
Official Title
Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia for Lower Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
September 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
This group will receive dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour
Arm Title
Magnesium Sulphate group
Arm Type
Active Comparator
Arm Description
This group will receive Magnesium Sulphate infusion at a rate of 15 mg/Kg/hour
Arm Title
Saline group
Arm Type
Placebo Comparator
Arm Description
This group will receive normal saline infusion
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
This group will receive Dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulphate
Intervention Description
This group will receive Magnesium sulphate infusion at a rate of 15 mg/Kg/hour
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
This group will receive normal saline infusion
Primary Outcome Measure Information:
Title
Duration of analgesia
Description
Duration of analgesia after the operation defined as the time till the first analgesic request by the patient
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Systolic blood pressure measured in mmHg
Time Frame
6 hours
Title
Diastolic blood pressure
Description
Diastolic blood pressure measured in mmHg
Time Frame
6 hours
Title
Heart rate
Description
The number of heart beats per minute
Time Frame
6 hours
Title
Onset of sensory block
Description
The time needed to have complete sensory block after spinal anesthesia measured in minutes
Time Frame
30 minutes after spinal anesthesia
Title
Onset of motor block
Description
The time needed to have complete motor block after spinal anesthesia measured in minutes
Time Frame
30 minutes after spinal anesthesia
Title
Duration of motor block
Description
The time needed for recovery of motor motor after spinal anesthesia measured in hours
Time Frame
12 hours
Title
Ramsay Sedation Scale
Description
A scale used for assessment of sedation level ranges from 1 (combative) to 6 (unarousable)
Time Frame
12 hours after spinal anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inas Farouk, Lecturer
Organizational Affiliation
Lecturer of anesthesia
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

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