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Ketamine- Propofol Versus Pethidine- Propofol in ERCP

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ClinicalTrials.gov Identifier: NCT02651792
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
khaled salah mohamed, Assiut University

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

Condition or disease Intervention/treatment Phase
Sedation in ERCP Drug: ketamine- propofol Drug: pethidine- propofol Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Ketamine-propofol Versus Pethidine-propofol for Sedating Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)
Study Start Date : January 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ketamine- propofol
IV Ketamine 1mg/kg + Propofol 1.2 mg/kg will be given for sedation.
Drug: ketamine- propofol
1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.
Other Name: N01AX03 - Propofol

Active Comparator: pethidine- propofol
1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction
Drug: pethidine- propofol
1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction
Other Name: meperidine - Propofol




Primary Outcome Measures :
  1. endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition) [ Time Frame: Immediately after procedure. ]

Other Outcome Measures:
  1. amount of propofol consumed during procedure [ Time Frame: Immediately after procedure. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651792


Locations
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Egypt
Al Rajhy liver hospital
Asyut, Egypt, 71515
Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Mostafa S Abbas, MD Assiut University

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Responsible Party: khaled salah mohamed, lecturer of anaesthesia and ICU, Assiut University
ClinicalTrials.gov Identifier: NCT02651792     History of Changes
Other Study ID Numbers: ketfol versus pethidine
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Keywords provided by khaled salah mohamed, Assiut University:
ketamine
propofol
pethidine
ERCP
endoscopist
Additional relevant MeSH terms:
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Meperidine
Ketamine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia