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Comparison of Sublingual buprenorphine and intravenous morphine for postoperative analgesic effect hemodynamic changes, nausea & vomiting

Protocol summary

Summary
In this study, we compare sublingual buprenorphine and intravenous morphine for postoperative analgesic effect, hemodynamic changes, nausea, and vomiting. A total of 100 patients, aged 18-60 years old, and in ASA Class I, II, undergoing lower limbs orthopedic surgery, herniorraphy, or varicocelectomy were studied. The patients were randomly assigned to receive sublingual buprenorphine (0.4mg) or IV morphine (6mg) before administration of analgesic after the operation. Vital signs, o2sat, pain severity, nausea & vomiting, itching, respiratory rates, and hemodynamic changes were assessed and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012203305N2
Registration date: 2011-01-31, 1389/11/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-01-31, 1389/11/11
Registrant information
Name
Ebrahim Alijanpour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1228 0013
Email address
dralijanpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research, Babol University Of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sublingual buprenorphine and intravenous morphine for postoperative analgesic effect hemodynamic changes, nausea & vomiting
Public title
Comparison of Sublingual buprenorphine and intravenous morphine for postoperative analgesic effect hemodynamic changes, nausea & vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-60 years old, ASA Class I, II, candidate for lower limbs orthopedic surgery, herniorraphy, or varicocelectomy Exclusion criteria: History of complications such as: respiratory, cardiovasculer diseases, hypertension, diabetes mellitus, or addiction
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University Of Medical Sciences
Street address
University Square, Ganjafrooz Avenue, Babol
City
Babol
Postal code
Approval date
2010-04-20, 1389/01/31
Ethics committee reference number
164/30/ژ/پ

Health conditions studied

1

Description of health condition studied
Spinal anesthesia in ASA ClassI, II
ICD-10 code
Other comp
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
Postoperative analgesic effect
Timepoint
before intervention untill 12 hours after intervention
Method of measurement
Visual analogue pain score

2

Description
Hemodynamic changes
Timepoint
before intervention untill 12 hours after intervention
Method of measurement
Pulse Oxymeter , Sphigmo manometer

3

Description
Nausea & Vomiting
Timepoint
Before intervention untill 12 hour after intervention
Method of measurement
Visual - questional

Secondary outcomes

1

Description
Oxygen saturation
Timepoint
15, 30, 60 min after procedure, half an hour, before and after 2 and 12 hours
Method of measurement
pulse oximeter

Intervention groups

1

Description
Sublingual buprenorphine 0.4mg as well as 6 ml N/S as placebo
Category
Prevention

2

Description
IV morphine 6mg in 3 min as well as a sublingual tab as placebo
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol Beheshti Hospital
Full name of responsible person
Dr Ebrahim Alijanpour
Street address
City
Babol

2

Recruitment center
Name of recruitment center
Babol Yahyanejad Hospital
Full name of responsible person
Dr Ebrahim Alijanpour
Street address
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Babol University Of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Street address
University Square, Ganjafrooz Avenue, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Babol University Of Medical Sciences
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
Babol University Of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Babol
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
dralijanpour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital,
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
dralijanpour@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Other areas of specialty/work
Street address
Ruhani Hospital
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
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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