Intrathecal Fentanyle Versus Dexamethasone in Gynacologic... | NCT04779060

Studies
Intrathecal Fentanyle Versus Dexamethasone in Gynacological Laparoscopic Surgeries

NCT04779060

Sponsor

Assiut University

Status

Completed

Last Update Posted

Mar 17, 2021Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Intraoperativ Pain

Interventions

intrathecal fentanyle
dexamethasone
saline

Countries

Egypt

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Sep 2020Actual

Completion Date

Sep 2020Actual

First Submitted Date

Feb 27, 2021

First Submission Date that Met QC Criteria

Feb 27, 2021

First Posted Date

Mar 3, 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

Mar 15, 2021

Last Update Posted Date

Mar 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Laparoscopy was first introduced to the medical field of in the middle of the last century. It revolutionized the surgical interventions; it reduced the total medical expenditures and hastened postoperative recovery . General anaesthesia (GA) was considered the only anesthetic technique suitable for laparoscopic interventions, and several myths and facts prevented regional anaesthesia (RA) implementation. Respiratory and Cardiovascular impairment were the main aspects of concern which are thought to be best controlled by GA

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

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
fentanyle group	Active Comparator	Drug: intrathecal fentanyle
dexamethasone group	Active Comparator	Drug: dexamethasone
control group	Placebo Comparator	Drug: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intrathecal fentanyle	Drug	25 mic fentanyle added to heavy bupivacaine for spinal anesthesia	fentanyle group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intraoperative pain	pain measured by VAS score =from 0 to 10 0-3 is mild pain 3-6 moderate pain 6-10 sever pain	60 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I, II
elective gynacological laparoscopic surgery

Exclusion Criteria:

patient refusal
chronic kidney and hepatic diseases

Accepts Healthy Volunteers

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university		Asyut		71111	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided