CClinicalTrials.gg
Status unknownNCT03747094SedBaloonUpdated Nov 20, 2018

Sedation of Morbidly Obese for Balloon Insertion

An interventional study of Fentanyl and Ketamine in Morbid Obesity, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-11-20.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
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Study 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.

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Conditions studied

  • Morbid Obesity

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03

In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's planned enrollment of 70 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • morbid obese indicated for gastric balloon insertion

Exclusion criteria

Exclusion Criteria:

  • Refusal Hypersensitivity to any of the study drugs
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Fentanyl group

    Drug: Fentanyl

  • Experimental
    Ketamine group

    Drug: Ketamine

Interventions

  • DrugFentanyl

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

  • DrugKetamine

    0.25 mg ketamine will be administered immediately before the procedure

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What researchers measure

Primary outcomes

  1. Propofol consumption (milligrams)

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

    Time frame: 24 hours after the endoscopy

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Study locations

1 site
  • Mansoura university
    Al Manşūrah, Dkahleya, Egypt
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03747094
Lead sponsor
Mansoura University
Responsible party
AlRefaey Kandeel (lecturer of anesthesia, Mansoura University) — Principal investigator
First posted
Nov 20, 2018
Start date
Dec 1, 2018 (estimated)
Primary completion
Mar 20, 2019 (estimated)
Completion
Apr 15, 2019 (estimated)
Last update
Nov 20, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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