A comparative evaluation of perioperative complications of intrathecal sufentanil and fentanyl in combination with bupivacaine and bupivacaine alone for lower limb orthopedic surgery
Objective: A comparative evaluation of perioperative complications of intrathecal sufentanil and fentanyl in combination with bupivacaine and bupivacaine alone for lower limb orthopedic surgury.
Inclusion criteria: adults aged 18-65 years; American Society of Anesthesiology classification of 1-2; No contraindication for spinal anesthesia; No history of opium abuse; No history of neurologic, neuromuscular or psychological disorders; no history of allergic reaction to local anesthetic
Exclusion criteria: request for analgesic drugs or opioids during spinal anesthesia; need for general anesthesia during operation; pregnancy
Target population: all adults aged 18-65 years candidate for lower extremities orthopedic surgery in Hazrat Rasoul Medical Center and Firouzgar hospital.
Sample size: there are three groups in the study; we will assign 30 patients for each group randomly.
Interventions: in first group we will administrate intrathecally 15mg Bupivacaine 0.5% with 5 microgram sufentanil , in second group we will administrate intrathecally 15mg Bupivacaine 0.5% with 25 microgram fentanyl and in the control group we will administrate intrathecally 15mg Bupivacaine 0.5% with 0.5 ml Distilled water.
This study will be finalized in 12 months in2010-2011.
Primary outcome: mean arterial pressure and hemodynamic changes will be evaluated in all three groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209045822N2
Registration date:2012-10-14, 1391/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-14, 1391/07/23
Registrant information
Name
Valiollah Hassani
Name of organization / entity
Department of Anesthesiology, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
valiollah_hassani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative evaluation of perioperative complications of intrathecal sufentanil and fentanyl in combination with bupivacaine and bupivacaine alone for lower limb orthopedic surgery
Public title
Effect of adding fentanyle and sufentanil to bupivacaine in spinal anesthesia in perioperative complications of orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: adults aged 18-65 years; American Society of Anesthesiology classification of 1-2; No contraindication for spinal anesthesia; No history of opium abuse; No history of neurologic, neuromuscular or psychological disorders; no history of allergic reaction to local anesthetic
Exclusion criteria: request for analgesic drugs or opioids during spinal anesthesia; need for general anesthesia during operation; pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Tehran University of Medical Sciences
Street address
Room 501, 5th Floor, Central Office of Tehran University of Medical Sciences, Keshavarz Bolvard
City
Tehran
Postal code
Approval date
2012-05-27, 1391/03/07
Ethics committee reference number
203/130/د/91
Health conditions studied
1
Description of health condition studied
lower limb bone fracture
ICD-10 code
M84
ICD-10 code description
Disorders of continuity of bone
Primary outcomes
1
Description
Mean Arterial Pressure
Timepoint
every 2 min til 20 min, then every 5 min until transfering the patient to the recovery then every 15 min until transfering to the ward.
Method of measurement
Electronic sphygmometer
Secondary outcomes
1
Description
O2 Saturation
Timepoint
every 2 min til 20 min, then every 5 min until transfering the patient to the recovery then every 15 min until transfering to the ward.
Method of measurement
pulse oximetry
2
Description
Heart rate
Timepoint
every 2 min til 20 min, then every 5 min until transfering the patient to the recovery then every 15 min until transfering to the ward.
Method of measurement
pulse oximetry
3
Description
Maximum height of sencory block
Timepoint
10 min after intervention
Method of measurement
physcial examination
4
Description
Ephedrin administration
Timepoint
when blood pressure decrease to20% of base or below 100mmhg
Method of measurement
yes/ no
5
Description
Bradicardia
Timepoint
when Heart rate decreases below 60 per min.
Method of measurement
pulse oximetry
Intervention groups
1
Description
sufentanil Group: we will administrate intrathecally 15mg Bupivacaine 0.5% (Bupivacaine®، Milan Co، Italy) with 5 microgram Sufetanil (Sufenta، Janssen-Cilag, India)
Category
Treatment - Drugs
2
Description
Fentnyll group: we will administrate intrathecally 15mg Bupivacaine 0.5% (Bupivacaine®، Milan Co، Italy) with 25 microgram fetanyl (Fentanyl, Abureyhan, Iran)
Category
Treatment - Drugs
3
Description
Control group: we will administrate intrathecally 15mg Bupivacaine 0.5% (Bupivacaine®، Milan Co، Italy) with 0.5 ml Distilled water
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Hospital
Full name of responsible person
Valiollah Hassani
Street address
Niyayesh St, Sattarkhan St.
City
Tehran
2
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Maryam Hajiashrafi
Street address
Valiasr Sq., Behafarin St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Ghodrati
Street address
Firouzgar Hospital, Behafarin St. ,Valiasr Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Hazrat Rasoul Medical Center, Niayesh st, Sattarkhan ave,
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
vhassani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Hazrat Rasoul Medical Center, Niayesh St, Sattarkhan ave,
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
vhassani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Hajiashrafi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Hazrat Rasoul Medical Center, Niayesh St, Sattarkhan St.
City
Tehran
Postal code
Phone
00
Fax
Email
maryam_hajiashrafi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)