NCT02362022

Brief Summary

Combination of volatile and opioid agents are used to achieve unconsciousness, haemodynamic stability and analgesia for surgical prosedures. This prospective, randomized, double-blind, controlled study evaluates the effects of two different doses of morphine sulphate (0.1 mg/kg and 0.2 mg/kg), on desflurane consumption, recovery characteristics, postoperative analgesic requirements and side effects during total abdominal hysterectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
Last Updated

December 3, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

February 4, 2015

Last Update Submit

December 2, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • postoperative desflurane consumption

    postoperative first hour

  • sedation scores for OASS scale

    postoperative first hour

Study Arms (3)

Group Saline

PLACEBO COMPARATOR

Group Saline (Group S) received i.v saline 0.9 % in 10 ml volume (n=30)

Drug: Morphine

Group Morphine 1

ACTIVE COMPARATOR

Group Morphine 1 (Group M1) received i.v morphine 0.1 mg kg-1, in 10 ml volume (n=30)

Drug: Morphine

Group Morphine 2

ACTIVE COMPARATOR

Group Morphine 2 (Group M2) received i.v morphine 0.2 mg kg-1, in 10 ml volume (n=30)

Drug: Morphine

Interventions

Group Saline (Group S): Received i.v saline 0.9 % in 10 ml volume (n=30) Group Morphine 1 (Group M1): Received i.v morphine 0.1 mg kg-1 in 10 ml volume (n=30) Group Morphine 2 (Group M2): Received i.v morphine 0.2 mg kg-1 in 10 ml volume (n=30)

Group Morphine 1Group Morphine 2Group Saline

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • undergoing total abdominal hysterectomy with general anaesthesia

You may not qualify if:

  • renal dysfunction (cre\>1.2), liver failure, cardiovascular, psychiatric, allergic and metabolic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University School of Medicine Adana Teaching and Research Hospital

Adana, 01250, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • cagla bali

    Baskent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 12, 2015

Study Start

September 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 3, 2015

Record last verified: 2015-06

Locations