Intravenous Remifentanil Plus Morphine or Morphine Alone... | NCT01830296

Studies
Intravenous Remifentanil Plus Morphine or Morphine Alone for Postthoracotomy Pain

NCT01830296

Sponsor

Cukurova University

Status

Completed

Last Update Posted

Apr 12, 2013Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Pain

Interventions

Remifentanil+morphine

Countries

Turkey (Türkiye)

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 2013

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

May 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 27, 2013

First Submission Date that Met QC Criteria

Apr 10, 2013

First Posted Date

Apr 12, 2013Estimated

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 10, 2013

Last Update Posted Date

Apr 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background; Post-thoracotomy pain remains a major problem. This double-blind, randomized study tested the effects of coadministration of patient controlled remifentanil+morphine combination on postthoracotomy pain, analgesic consumption and side effects compared with morphine PCA alone

Detailed Description

Methods; Sixty patients were allocated randomly to receive an intravenous patient-controlled analgesia with morphine alone (M), or morphine plus remifentanil (MR), in a double-blind manner. Postoperatively patients were allowed to use bolus doses of morphine (0.2 mg kg-1) or morphine (0.2 mg kg-1) plus remifentanil (0.2 µg kg-1) mixture every 10 min without a background infusion. Pain, discomfort, sedation scores, total and bolus patient-controlled morphine consumption, rescue analgesic requirement and side-effects were recorded for up to 24 h after the start of patient-controlled analgesia.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Remifentanil+Morphine	Active Comparator	Morphine(M) Remifentanil+Morphine(MR)	Drug: Remifentanil+morphine
IV morphine PCA	Active Comparator	IV remifentanil+morphine PCA	Drug: Remifentanil+morphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remifentanil+morphine	Drug	Morphine, Remifentanil+Morphine	IV morphine PCA Remifentanil+Morphine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
COADMINISTRATION OF INTRAVENOUS REMIFENTANIL AND MORPHINE FOR POSTTHORACOTOMY PAIN; COMPARISON WITH IV MORPHINE ALONE	As aim of this study was to evaluate the effects of remifentanil addition to morphine for i.v. PCA on analgesic consumption, the primary endpoint was defined as morphine consumption at 24 hour.	Two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

60 ASA physical status I-III patients, between the ages of 18 and 59 years, scheduled for elective thoracotomy surgery with general anaesthesia were included in this study

Exclusion Criteria:

severe hepatorenal disease history, sensitivity or contraindication to morphine and remifentanil, chronic pain (defined as regular use of opioid analgesics for > 3 months), drug or alcohol abuse and contraindication to administration of PCA

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mediha Turktan, Assist Prof	Cukurova University, Department of Anaesthesiology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hakkı Unlugenc		Adana		01330	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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