Protocol summary

Summary
Objectives: Comparison the effect of intrathecal meperidine and fentanil added to bupivacaine 0.5% for elective Cesarean section. Study Design: a randomized, double-blind, clinical trial. Inclusion criteria: pregnant women, ASA I-II with singleton pregnancies who were underwent elective Caesarean section, Exclusion criteria: Patients with cardiovascular disorders, renal failure, coagulopathy, sensitivity to the drugs, preeclampsia, lack of consent and spinal anesthesia contraindication, history of seizures or other neurological diseases, (IUGR). 120 Patients were randomly divided into 3 groups: Group1 : bupivacaine 0.5% (8mg), 15 micrograms fentanil and 0.1 ml normal saline total volume 2ml.Group2 : bupivacaine 0.5% (8mg), 15 mg of meperidine and 0.1 ml normal saline total volume 2ml. Group3: bupivacaine 0.5% (10 mg) (total volume 2 ml. Measured variables: Time of onset: the time interval intrathecal injection and loss of sensation in the T10, The maximum level of sensory block and time to reach to the maximum level of sensory block, the level of sensory block after 120 min, the duration of sensory block, Onset of motor block, duration of motor block, the maximum level of motor block, shivering, pruritus, nausea, vomiting were checked during and after operation every 10 min in the recovery room every 10 min, Hypertension, bradycardia, time of discharge from recovery room, Apgar score at 1 and 5 minutes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015013119470N14
Registration date: 2015-02-09, 1393/11/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-09, 1393/11/20
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative effect of fentanyl and meperidine added to 8 mg bupivacaine for spinal anesthesia in elective cesarean section surgery
Public title
A Comparative effect of fentanyl and meperidine added to 8 mg bupivacaine for spinal anesthesia in elective cesarean section surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women, ASA I-II with singleton pregnancies who were underwent elective Caesarean section, Exclusion criteria: Patients with cardiovascular disorders, renal failure, coagulopathy, sensitivity to the drugs, preeclampsia, lack of consent and spinal anesthesia contraindication, history of seizures or other neurological diseases, (IUGR).
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CP-P-9365-6925

Health conditions studied

1

Description of health condition studied
cesarean
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
Determine the duration of sensory block in patients with intrathecal fentanyl added to bupivacaine 0.5%.
Timepoint
Perioperative and Post-operative
Method of measurement
Pinprick

Secondary outcomes

1

Description
To determine the duration of sensory block in patients receiving intrathecal meperidine with bupivacaine 0.5%.
Timepoint
Prioperative and post operative
Method of measurement
Pinprick Scale

Intervention groups

1

Description
Group1 : bupivacaine 0.5% (8mg), 15 micrograms fentanyl and 0.1 ml normal saline total volume 2ml.
Category
Treatment - Drugs

2

Description
Group2 :intrathecal bupivacaine 0.5% (8mg), 15 mg of meperidine and 0.1 ml normal saline total volume 2ml.
Category
Treatment - Drugs

3

Description
Group3:intrathecal bupivacaine 0.5% (10 mg) (total volume 2 ml)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research; Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
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; Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Azizolahi
Position
Physician, Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
azadehazizollahi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Mohammad Bagher Khosravi
Position
Cardio-Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
khosravimb@sums.ac.ir
Web page address

Person responsible for updating data

Contact

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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