NCT02618668

Brief Summary

The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic stability, recovery time ,patient \& doctor satisfaction scores during Endoscopic Retrograde Cholangiopancreatography.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

November 16, 2015

Last Update Submit

September 20, 2019

Conditions

PancreatitisCholangitis

Outcome Measures

Primary Outcomes (4)

  • mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography

    every 5 minutes up to 30minutes

  • saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography

    every 5 minutes up to 30 minutes

  • Heart rate( beat/minute) from baseline of patient

    every 5 minutes up to 30 minutes

  • Recovery score of patient

    up to 10 minutes after the end of procedure

Secondary Outcomes (1)

  • patient and doctor satisfaction score

    through study completion, an average of 1 year

Study Arms (2)

Ketamine / Propofol Admixture

EXPERIMENTAL

Ketamine / Propofol Admixture: I.V propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+ 4 ml saline in a 20-ml syringe which resulted in 0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol.

Drug: Ketamine / Propofol Admixture

Propofol

ACTIVE COMPARATOR

I.V propofol 2 mg/kg

Drug: Propofol

Interventions

Ketamine / Propofol AdmixtureDRUG

propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+4 ml saline in a 20-ml syringe which resulted in0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol

Ketamine / Propofol Admixture
PropofolDRUG

2 mg/kg I.V

Propofol

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists ( I ,II )

You may not qualify if:

  • Presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity.
  • History of substance abuse or dependence.
  • History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, 11111, Egypt

Location

MeSH Terms

Conditions

PancreatitisCholangitis

Interventions

KetaminePropofol

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesBile Duct DiseasesBiliary Tract Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, Aromatic

Study Officials

  • Mohamed A Bakr, Prof.

    Assiut University

    STUDY CHAIR

  • Nagwa m osman, Asst.prof.

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident of anesthesia and ICU, Assiut University

Study Record Dates

First Submitted

November 16, 2015

First Posted

December 1, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations

EG(1)