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Ketamine- Propofol Versus Pethidine- Propofol in ERCP

NCT ID: NCT02651792

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to \<90% , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation scores of all patients will be recorded perioperatively. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure.

Conditions

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Sedation in ERCP

Keywords

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ketamine propofol pethidine ERCP endoscopist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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ketamine- propofol

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

Group Type ACTIVE_COMPARATOR

ketamine- propofol

Intervention Type DRUG

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

pethidine- propofol

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

Group Type ACTIVE_COMPARATOR

pethidine- propofol

Intervention Type DRUG

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

Interventions

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ketamine- propofol

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

Intervention Type DRUG

pethidine- propofol

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

Intervention Type DRUG

Other Intervention Names

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N01AX03 - Propofol meperidine - Propofol

Eligibility Criteria

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Inclusion Criteria

* both gender
* age between 18-70

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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khaled salah mohamed

lecturer of anaesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mostafa S Abbas, MD

Role: STUDY_CHAIR

Assiut University

Locations

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Al Rajhy liver hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ketfol versus pethidine

Identifier Type: -

Identifier Source: org_study_id