Propofol for Prophylaxis of Morphine Induced Pruritis in... | NCT06188546

Studies
Propofol for Prophylaxis of Morphine Induced Pruritis in Caesarean Section

NCT06188546

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jan 3, 2024Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Pruritus Caused by Drug

Interventions

Propofol

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

Dec 2023

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

Jan 1, 2024Estimated

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Mar 1, 2025Estimated

First Submitted Date

Dec 19, 2023

First Submission Date that Met QC Criteria

Dec 19, 2023

First Posted Date

Jan 3, 2024Actual

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

Dec 19, 2023

Last Update Posted Date

Jan 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the goal of this randomized clinical trial is to find the optimum sub hypnotic dose of iv propofol that prevents the incidence of itching induced from intrathecal morphine used in spinal anesthesia in caesarean section operation. the main questions it aim to answer are the number of patients complained of pruritus in the first 24 hours post operative period and the severity of the pruritus. participants will be divided into 4 groups. 1st group receives 0 mg of propofol , 2nd receives 10 mg , 3rd receives 20 mg and the 4th receives 30 mg.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 0	Placebo Comparator	Will receive no drugs for pruritis prophylaxis	Drug: Propofol
Group 1	Active Comparator	Will receive 1ml of propofol 10 mg/ml	Drug: Propofol
Group 2	Active Comparator	Will receive 2 ml of propofol 10mg/ml	Drug: Propofol
Group 3	Active Comparator	Will receive 3 ml of propofol 10mg/ml	Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis	Group 0 Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of participants complained of pruritus in the first 24hr post operative period		first 24 hours post operative period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The study is scheduled for women undergoing elective caesarean section under spinal anesthesia.
The subject is ≥ 20 years and ≤ 40 years.
No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests.
ASA class 1-2.

Exclusion Criteria:

Patients who had a known allergy to propofol, morphine, or bupivacaine.
Those with preexisting pruritus caused by pregnancy, a coexisting skin disorder, or other pruritogenic systemic diseases.
Patients with a contraindication to spinal anaesthesia
Failed block
Need of extra sedation intra-operative
Positive history for asthma or COPD.
Patient refusal

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sohila K Hassan, MBBCH	Contact	201010328326		khaledsohila@gmail.com

Overall Officials

Name	Affiliation	Role
Zein Zarea, MD	Assiut University	Study Chair
Diab Fuad Hetta, MD	South Egypt's cancer institute	Study Director
Rania Mohamed Abdelemam, MD

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided