NCT03640390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_3 postoperative-pain

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

August 18, 2018

Last Update Submit

November 13, 2019

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Duration of analgesia

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

    24 hours

Secondary Outcomes (7)

  • Systolic blood pressure

    6 hours

  • Diastolic blood pressure

    6 hours

  • Heart rate

    6 hours

  • Onset of sensory block

    30 minutes after spinal anesthesia

  • Onset of motor block

    30 minutes after spinal anesthesia

  • +2 more secondary outcomes

Study Arms (3)

Dexmedetomidine group

EXPERIMENTAL

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

Drug: Dexmedetomidine

Magnesium Sulphate group

ACTIVE COMPARATOR

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

Drug: Magnesium Sulphate

Saline group

PLACEBO COMPARATOR

This group will receive normal saline infusion

Drug: Normal saline

Interventions

DexmedetomidineDRUG

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

Also known as: Precedex
Dexmedetomidine group
Magnesium SulphateDRUG

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

Magnesium Sulphate group
Normal salineDRUG

This group will receive normal saline infusion

Saline group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged between 18 and 65 years.
  • Scheduled for lower abdominal surgery.

You may not qualify if:

  • Systolic blood pressure less than 100 mmHg
  • Coagulation disorders
  • History of heart failure
  • Mitral or Aortic stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexmedetomidineMagnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Inas Farouk, Lecturer

    Lecturer of anesthesia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 18, 2018

First Posted

August 21, 2018

Study Start

August 30, 2018

Primary Completion

August 30, 2019

Study Completion

September 10, 2019

Last Updated

November 14, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)