NCT03747094

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

November 13, 2018

Last Update Submit

November 17, 2018

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • Propofol consumption (milligrams)

    Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion

    24 hours after the endoscopy

Study Arms (2)

Fentanyl group

ACTIVE COMPARATOR
Drug: Fentanyl

Ketamine group

EXPERIMENTAL
Drug: Ketamine

Interventions

FentanylDRUG

0.5 mic/kg fentanyl will be given immediately before the procedure

Fentanyl group
KetamineDRUG

0.25 mg ketamine will be administered immediately before the procedure

Ketamine group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • morbid obese indicated for gastric balloon insertion

You may not qualify if:

  • \- Refusal Hypersensitivity to any of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Manşūrah, Dkahleya, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

FentanylKetamine

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 20, 2018

Study Start

December 1, 2018

Primary Completion

March 20, 2019

Study Completion

April 15, 2019

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations

EG(1)