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Completed

NCT Number: NCT02651792

Ketamine- Propofol Versus Pethidine- Propofol in ERCP

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

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Key information

Conditions

Sedation in ERCP

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al Rajhy liver hospital

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine- propofol

Drug

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

Other names: N01AX03 - Propofol

pethidine- propofol

Drug

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

Other names: meperidine - Propofol

Primary outcomes

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

    Time frame: Immediately after procedure.

Other outcomes

  1. amount of propofol consumed during procedure

    Time frame: Immediately after procedure.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Ketamine-propofol Versus Pethidine-propofol for Sedating Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2016
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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