Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections

February 9, 2021 updated by: Baher Said Elshahat Mohamed Abdelhady, Benha University

A Comparative Study of Postoperative Analgesia of Different Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections

we designed this randomized, single -blind, prospective clinical study to test postoperative analgesia of three intrathecal additives in elective caesarean sections which are magnesium, dexamethasone and dexmedetomidine.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old )
  • Elective cesarean section under spinal anaesthesia
  • Gestational age > 37 weeks
  • BMI less than 30 kg/m2

Exclusion Criteria:

  • Patient refusal
  • unable to give consent
  • age < 18 or > 40
  • BMI more than 30 kg/m2
  • known allergy to the study medication
  • coagulopathies or on anticoagulant medications
  • diabetic neuropathy
  • patients with psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: magnesium intrathecal
Drug: intrathecal Magnesium
intrathecal adjuvants to bupivacaine
Active Comparator: dexamethasone intrathecal
Drug: intrathecal dexamthasone
intrathecal adjuvants to bupivacaine
Active Comparator: dexmedetomidine intrathecal
Drug: intrathecal dexmedetomidine
intrathecal adjuvants to bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesic effect
Time Frame: Up to 24 hours after surgery
duration of sensory block
Up to 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • spinal additives

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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