NCT02651792

Brief Summary

The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

November 29, 2015

Last Update Submit

April 27, 2016

Conditions

Sedation in ERCP

Keywords

ketaminepropofolpethidineERCPendoscopist

Outcome Measures

Primary Outcomes (1)

  • endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)

    Immediately after procedure.

Other Outcomes (1)

  • amount of propofol consumed during procedure

    Immediately after procedure.

Study Arms (2)

ketamine- propofol

ACTIVE COMPARATOR

IV Ketamine 1mg/kg + Propofol 1.2 mg/kg will be given for sedation.

Drug: ketamine- propofol

pethidine- propofol

ACTIVE COMPARATOR

1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction

Drug: pethidine- propofol

Interventions

ketamine- propofolDRUG

1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.

Also known as: N01AX03 - Propofol
ketamine- propofol
pethidine- propofolDRUG

1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction

Also known as: meperidine - Propofol
pethidine- propofol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • both gender
  • age between 18-70

You may not qualify if:

  • pregnant patients.
  • morbid obesity.
  • chronic obstructive pulmonary disease.
  • complicated airway.
  • American society of anesthesia (ASA) physical classification IV-V.
  • history of allergy or contraindications to the drugs used in the study
  • emergency need for ERCP.
  • those whose informed consent could not be signed.
  • those with possible complex ERCP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Rajhy liver hospital

Asyut, 71515, Egypt

Location

Study Officials

  • Mostafa S Abbas, MD

    Assiut University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia and ICU

Study Record Dates

First Submitted

November 29, 2015

First Posted

January 11, 2016

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations

EG(1)