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Comparison of patient-controlled analgesia with morphine and target-controlled analgesia with sufentanil in controlling post-operative pain

Protocol summary

Summary
40 patients 18-60 years old after major surgical operation (laparatomy, vertebral column operation, head and neck surgeries, pelvic operation, femoral operation) randomly will be allocated in one of two groups: PCA with morphine and TCI with sufentanil. The patients should be awake and no artificial ventilation needed. In the first group, patients will receive morphine sulphate with PCA pump 1 mg IV as bolus dose, then 1 mg/hour as continuous dose and 1 mg when patients demand (with lock out time of 20 min), in second group after operation, patients will receive sufentanil as analgesic with TCI pump with brain target concentration of 0.2 ng/ml. The goal of analgesic administration is to keep visual analogue scale(VAS) less than 3. VAS will be measured and recorded every 2 hour. If VAS>3, the continuous dose of morphine will be increased to 2 mg/h in the first group and the target brain concentration will be increased to 0.3 in second group. The mean of VAS in 24h after operation in two groups will be compared. Side effects such as nausea and vomiting, pruritus, depressed ventilation, decreased consciousness and vital signs will be compared between two groups. Ease of use of pump by personnel and patients satisfaction will also be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138707271361N1
Registration date: 2009-01-04, 1387/10/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-01-04, 1387/10/15
Registrant information
Name
Naser Yeganeh
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
4276309 831 98+
Email address
nyeganeh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pro-Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Expected recruitment start date
2008-12-30, 1387/10/10
Expected recruitment end date
2009-06-30, 1388/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of patient-controlled analgesia with morphine and target-controlled analgesia with sufentanil in controlling post-operative pain
Public title
Comparison of two methods of analgesia after major surgical operations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having been carried out a major surgical operation, Being awake in postoperative period, Age 18-60, Exclusion criteria: Denial of patients, Depressed consciousness, Need for mechanical ventilation after operation, Dependence to opium or other sedatives like Benzodiazepines.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences ethical committee
Street address
Kermanshah University of Medical Sciences, Pro-Vice-Chancellor for Research
City
Kermanshah
Postal code
Approval date
2008-05-18, 1387/02/29
Ethics committee reference number
87021

Health conditions studied

1

Description of health condition studied
Post operative analgesia
ICD-10 code
Y45.o
ICD-10 code description
complication of medical and surgical care-opioids and related analgesics

Primary outcomes

1

Description
Pain
Timepoint
every 2 hours until 24 hours after surgery
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Nausea and Vomiting
Timepoint
every 2 hours until 24 hours after operation
Method of measurement
observation

2

Description
Level of Consciousness
Timepoint
every 2 hours until 24 hours after operation
Method of measurement
observation,clinical examination (GCS)

3

Description
Pruritus
Timepoint
24 hours after operation
Method of measurement
observation,clinical examination

4

Description
Hemodynamic changes
Timepoint
every 2 hours until 24 hours after operation
Method of measurement
clinical examination

5

Description
Rrespiratory Rate
Timepoint
every 2 hours until 24 hours after operation
Method of measurement
observation,clinical examination

Intervention groups

1

Description
Infusion of morphine as analgesic with PCA pump
Category
Treatment - Drugs

2

Description
Infusion of sufentanil as analgesic with TCI pump
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital in Kermanshah University of Medical Sciences
Full name of responsible person
Naser yeganeh - Sharareh Abdolmaleki
Street address
City

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pro-Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr. H.Khazaie
Street address
Pro-Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
City
kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pro-Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Sharareh Abdolmaleki
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Imam Reza Hospital, Departement of Anesthesia and intensive care
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
nyeganeh@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam reza hospital
Full name of responsible person
Naser Yeganeh
Position
Anesthesiologist/Assisstant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
nyeganeh@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Naser Yeganeh
Position
Anesthesiologist/Assisstant Professor
Other areas of specialty/work
Street address
Departement of Anesthesia and Intensive Care
City
Kermanshah
Postal code
Phone
Fax
Email
nyeganeh@kums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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