Intrathecal Additives for Spinal Anaesthesia in Elective... | NCT04747171

Studies
Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections

NCT04747171

Sponsor

Benha University

Status

Unknown status

Last Update Posted

Feb 10, 2021Actual

Enrollment

105Estimated

Phase

Not Applicable

Conditions

Pain, Postoperative

Interventions

intrathecal Magnesium
intrathecal dexamthasone
intrathecal dexmedetomidine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2021Estimated

Primary Completion Date

Jun 2021Estimated

Completion Date

Jul 2021Estimated

First Submitted Date

Feb 5, 2021

First Submission Date that Met QC Criteria

Feb 9, 2021

First Posted Date

Feb 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2021

Last Update Posted Date

Feb 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Baher Said Elshahat Mohamed Abdelhady, Principal Investigator, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
magnesium intrathecal	Active Comparator	Drug: intrathecal Magnesium
dexamethasone intrathecal	Active Comparator	Drug: intrathecal dexamthasone
dexmedetomidine intrathecal	Active Comparator	Drug: intrathecal dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intrathecal Magnesium	Drug	intrathecal adjuvants to bupivacaine	magnesium intrathecal

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided