Protocol summary

Summary
The aim of this double-blind, randomized clinical trial study is to demonstrate the incidence and intensity of intra- and post-operative shivering on Seventy parturients;American Society of Anesthesiologists (ASA) physical status I to II; aged 18 to 40 years who will refer to Jahrom University of Medical Sciences educational hospitals for elective cesarean section under spinal anesthesia. We will exclude those Parturients who had contraindication to the local anesthesia and caesarean section surgery, diabetes, preoperative body temperature>38 C(fever), sever preeclampsia, allergy to the study medications (meperidine and bupivacaine); ASA III and higher.We will enroll 70 parturients into the study and will divide them into two groups, randomly. The parturients in case group will receive 10 mg bupivacaine 0.5% plus 10 mg meperidine and those in control group will receive 10 mg bupivacaine 0.5% plus 10 mg normal saline as a placebo. Finally, all data will be collected by a blinded observer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012090410743N1
Registration date: 2012-11-30, 1391/09/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-30, 1391/09/10
Registrant information
Name
Mohammad Yasin Karami
Name of organization / entity
Shiraz University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 1334 0405
Email address
yasin_karami@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research -Jahrom University of Medical Sciences
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2012-10-16, 1391/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of low dose intrathecal meperidine on intra- and post-operative shivering in caesarean section under spinal anesthesia:a prospective double-blind, randomized Clinical Trial
Public title
Meperidine effect on intraoperative and postoperative shivering of caesarean section under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: parturients [ASA physical status I or II]; age between 18 - 40 years old. exclusion criteria: sever preeclampsia; contraindication to local anesthesia and caesarean section surgery; diabetes; preoperative body temperature>38ᴏC (fever); allergy to the study medications (meperidine and bupivacaine); ASA III; drug addiction; height <152 cm; Raynaud’s syndrome; hypo or hyperthyroidism; BMI less than 19; BMI high than 25;
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Jahrom University of Medical Sciences ethics Committee
Street address
Ostad Motahhari Street, site of Paradise
City
jahrom
Postal code
987414846199
Approval date
2012-08-04, 1391/05/14
Ethics committee reference number
3812/A/D

Health conditions studied

1

Description of health condition studied
Spinal anesthesia
ICD-10 code
O29.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during pregnancy

Primary outcomes

1

Description
Shivering incidence
Timepoint
Spinal Anesthesia to recovery room
Method of measurement
Crossley and Mahajan Scale

2

Description
Shivering Intensity
Timepoint
Spinal Anesthesia to recovery room
Method of measurement
Crossley and Mahajan Scale

3

Description
Systolic Blood Pressure
Timepoint
Start to end Of Surgery
Method of measurement
mmHg

4

Description
Central Core Tempreture
Timepoint
Start to end Of Surgery
Method of measurement
Celcious

5

Description
BMI
Timepoint
Start of Study
Method of measurement
KG/M2

6

Description
APGAR Score
Timepoint
Post birth
Method of measurement
APGAR Scale

7

Description
highest block Segment
Timepoint
each 5 minutes during first 30 minutes of post Spinal anesthesia
Method of measurement
Pinprick

8

Description
Diastolic Blood pressure
Timepoint
Start to end Of Surgery
Method of measurement
mmHg

9

Description
Basic heart rate
Timepoint
Start to end Of Surgery
Method of measurement
beats per min

10

Description
Basic peripheral oxygen saturation
Timepoint
Start to end Of Surgery
Method of measurement
Percent

11

Description
Surgery Duration
Timepoint
Start to end Of Surgery
Method of measurement
Minute

12

Description
Time to reach highest block
Timepoint
Anesthesia onset
Method of measurement
minute

13

Description
Sensory Level
Timepoint
Anesthesia onset
Method of measurement
Range

Secondary outcomes

1

Description
Nausea And Vomitting
Timepoint
Post operation
Method of measurement
Observation

2

Description
pruritus
Timepoint
Post operation
Method of measurement
Patient feel

3

Description
Respiratory distress
Timepoint
During and Post operation
Method of measurement
Observation

4

Description
Hypotension
Timepoint
During and Post operation
Method of measurement
mmHg

5

Description
Bradycardia
Timepoint
During and Post operation
Method of measurement
Beat per minute

6

Description
Tachycardia
Timepoint
During and Post operation
Method of measurement
Beat per minute

Intervention groups

1

Description
10 mg bupivacaine 0.5% and 10 mg meperidine by Spinal Anesthesia (group BP, n=35)
Category
Prevention

2

Description
placebo (10 mg bupivacaine 0.5% and normal saline, (group B, n=35) by spinal Anesthesia.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahhari Hospital, Jahrom University of Medical Sciences
Full name of responsible person
Dr. Hasan Zabetian
Street address
Anesthesia Department, Motahari hospital, Jahrom University of Medical Sciences, Motahari Avenue, Jahrom, Iran
City
Jahrom

2

Recruitment center
Name of recruitment center
Peymanieh Hospital of Jahrom University of Medical Sciences
Full name of responsible person
Dr. Hasan Zabetian
Street address
Anesthesia Department, Peymanieh Hospital of Jahrom University of Medical Sciences, Vali-asr Avenue, Jahrom, Iran
City
Jahrom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research -Jahrom University of Medical Science
Full name of responsible person
Morteza Pourahmad
Street address
Jahrom University of Medical Sciences
City
Jahrom
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 -Jahrom University of Medical Science
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
Jahrom University of Medical Sciences
Full name of responsible person
Hasan Zabetian
Position
Associated Professor of Anesthesiology Department
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences
City
Jahrom
Postal code
Phone
+98 79 1334 0405
Fax
Email
h_zabetian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom university of Medical Sciences
Full name of responsible person
Mohammad Yasin Karami
Position
General Practicioner
Other areas of specialty/work
Street address
Motahhari Ave, Student Research Committee, Faculty of Medicine, Jahrom University of Medical Sciences, Jahrom, I.R.Iran
City
Jahrom
Postal code
Phone
+98 79 1334 0405
Fax
Email
yasinkarami@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Scciences
Full name of responsible person
Mohammad Amin Ghobadifar
Position
Medical Student
Other areas of specialty/work
Street address
Jahrom University of Medical Scciences
City
Jahrom
Postal code
Phone
00
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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