Ketamine- Propofol Versus Pethidine- Propofol in ERCP | NCT02651792

Studies
Ketamine- Propofol Versus Pethidine- Propofol in ERCP

NCT02651792

Sponsor

Assiut University

Status

Completed

Last Update Posted

Apr 29, 2016Estimated

Enrollment

50Actual

Phase

Phase 2

Conditions

Sedation in ERCP

Interventions

ketamine- propofol
pethidine- propofol

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Nov 29, 2015

First Submission Date that Met QC Criteria

Jan 8, 2016

First Posted Date

Jan 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2016

Last Update Posted Date

Apr 29, 2016Estimated

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ketamine- propofol	Drug	1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.	ketamine- propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)		Immediately after procedure.

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
amount of propofol consumed during procedure		Immediately after procedure.

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mostafa S Abbas, MD	Assiut University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al Rajhy liver hospital		Asyut		71515	Egypt