NCT02203175

Brief Summary

Pain on injection of propofol is a comman problem. The investigators planned to evaluate the effect of propofol-fentanyl mixture on propofol injection pain and compare it with fentanyl pretreatment and control groups. Following ethics committee approval, 150 ASA I,II patients (18-65 yr) undergoing general anesthesia were enrolled to this study. Exclusion criteria were communication difficulty, psychiatric, neurologic disorders and history of allergy. Patients were randomly assigned to one of tree equal groups. Before the anesthesia induction, Group C (Control, n=50) and group M (mixture, n=50) received 5 ml isotonic saline, group F (fentanyl, n=50)received 2micgr/kg fentanyl. 10 seconds after the study drugs had been given, a standart question about the comfort of the injection was asked to the patient. The investigators used the verbal rating scale (VRS) for evaluation of propofol injection pain. Statistical analyses were performed with Student's t and Fisher's exact tests; p value \<0,05 was considered significant. Demographic data was similar among the groups (table I) In group M, the number of the patients having propofol injection pain was significantly lower compared to groups F and C (p\<0,001 for both) None of the patients in groups F and M experienced severe pain whereas 24 patients (48%) had severe pain in group C (p\<0.001 for both). This study shown that fentanyl-propofol mixture is more effective compared to both fentanyl pretreatment and placebo in preventing propofol injection pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

June 30, 2014

Last Update Submit

September 23, 2014

Conditions

Pain

Keywords

propofolpretreatmentmixture

Outcome Measures

Primary Outcomes (1)

  • complete response

    The primary outcome is complete response: A complete response is defined as no pain during proposal injection.

    1 year

Study Arms (2)

Group C (plasebo): no pretreatment

PLACEBO COMPARATOR

saline injection

Drug: salineDrug: fentanylDrug: propofol

propofol and fentanyl

ACTIVE COMPARATOR

propofol 50 mg with fentanyl 50 mcgr iv during anesthesia induction ones time

Drug: fentanylDrug: propofol

Interventions

salineDRUG

Before the anesthesia induction, 5 ml isotonic saline

Also known as: serum phisyologic
Group C (plasebo): no pretreatment
fentanylDRUG

before the anesthesia induction 50 mcgr fentanyl

Also known as: talinat
Group C (plasebo): no pretreatmentpropofol and fentanyl
propofolDRUG

during anesthesia 50 mg proposal with 50 mcgr fentanyl

Also known as: pofol, diprivan
Group C (plasebo): no pretreatmentpropofol and fentanyl

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age
  • ASA status I-II
  • Scheduled for elective surgery

You may not qualify if:

  • Communication difficulty
  • Psychiatric and neurolojic disorders
  • History of allergy to the study drugs
  • Use of analgesics or sedative drugs within 24 hours before surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University Hospital

Istanbul, Devlet Yolu, Ankara Cad 102/104, Kozyatagi, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Sodium ChlorideFentanylPropofol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • ferdi menda, assoc. prof.

    Yeditepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 29, 2014

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

TU(1)