Sedation of Morbidly Obese for Balloon Insertion | NCT03747094

Studies
Sedation of Morbidly Obese for Balloon Insertion

NCT03747094

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Nov 20, 2018Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

Fentanyl
Ketamine

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

Nov 2018

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

Dec 1, 2018Estimated

Primary Completion Date

Mar 20, 2019Estimated

Completion Date

Apr 15, 2019Estimated

First Submitted Date

Nov 13, 2018

First Submission Date that Met QC Criteria

Nov 17, 2018

First Posted Date

Nov 20, 2018Actual

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

Nov 17, 2018

Last Update Posted Date

Nov 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This prospective study will assess the value of different supplements to orpofol bases anesthesia in morbidly obes e patients scheduled for balloon insertion. Two common drugs will be added to propofol bases anesthesia;Ketamine or fentanyl. Effect on prpofol consumption, post-procedure recovery profile, and patient satisfaction will be the study objectives.

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

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fentanyl group	Active Comparator		Drug: Fentanyl
Ketamine group	Experimental		Drug: Ketamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fentanyl	Drug	0.5 mic/kg fentanyl will be given immediately before the procedure	Fentanyl group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Propofol consumption (milligrams)	Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion	24 hours after the endoscopy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

morbid obese indicated for gastric balloon insertion

Exclusion Criteria:

- Refusal Hypersensitivity to any of the study drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 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
Mansoura university		Al Manşūrah	Dkahleya		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl
D007649	Ketamine

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D003510	Cyclohexanes

Browse Leaves

Not provided

Browse Branches

Not provided