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Comparison the Effects of Intrathecal Dexmedetomidine and Meperidine as Adjuvants to Bupivacaine 0.5% in the Woman Undergoing Elective Cesarean Section

Protocol summary

Summary
Objectives: The aim of this study was to compare the onset and duration of sensory and motor block, pruritus, shivering, and duration of analgesia and the effects in the newborn (Apgar) of dexmedetomidine or meperidine given intrathecally with 0.5% bupivacaine. Design: Conduction of a randomized, double-blind, clinical trial, method of randomization: simple randomization. Inclusion criteria: pregnant women, ASA I-II with singleton pregnancies who were underwent elective Caesarean section, term neonate, no contraindication for spinal anesthesia. Exclusion criteria: Patients with cardiovascular disorders, renal failure, coagulopathy, sensitivity to drugs, lack of consent and spinal anesthesia contraindication, history of seizures or other neurological diseases, (IUGR) Lack of proper growth of the fetus inside the uterus. 90 Patients were randomly divided into 3 groups to receive one of the following drugs for spinal anesthesia: Group D: 0.5% bupivacaine (10 mg) and dexmedetomidine 5 micrograms (Origin orion pharma Germany) (total volume 2.5 ml). Group M: 0.5% bupivacaine (10 mg) and 10 mg of meperidine (total volume 2.5 ml). Group P: 0.5% bupivacaine (10 mg) and 0.5 mL of normal saline without preservative (total volume 2.5 ml).Measured variables: Time of onset: the time interval intrathecal injection and loss of sensation in the T10 (by pinprick.),The time to reach the level of anesthesia to T6, The maximum level of sensory block (every 5 minutes or 20 minutes),The duration of sensory block (reduction of the maximum height of 2 level of sensory block), Onset of motor block Bromage score Modified about 1, The duration of motor block (reduced to zero and Modified Bromage score, The patient sedation (10 minutes after arrival to the recovery) based on the Modified ramsay sedation scale, Duration of anesthesia (spinal onset until the patient is complaining of pain), Apgar score at 1 and 5 minutes, Hypertension, Heart Rate, Nausea, vomiting, itching, shivering in recovery .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100814372N4
Registration date: 2015-02-02, 1393/11/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-02, 1393/11/13
Registrant information
Name
Simin Azemati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4270
Email address
azemati@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effects of Intrathecal Dexmedetomidine and Meperidine as Adjuvants to Bupivacaine 0.5% in the Woman Undergoing Elective Cesarean Section
Public title
Comparison the Effects of Intrathecal Meperidine and Dexmedetomidine added to Bupivacaine in the Woman Undergoing Cesarean Section.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women ASA I-II; singleton pregnancies; elective Caesarean section; term neonate; no contraindication for spinal anesthesia. Exclusion criteria :heart diseases; liver diseases; renal failure; coagulopathy; sensitivity to drugs; lack of consent; spinal anesthesia contraindication;a history of seizures; 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: 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
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-c-9368-6738

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
the duration of sensory block
Timepoint
Perioperative every 20 min and Post-operative 10 min after arrival to the recovery room
Method of measurement
Pinprick

Secondary outcomes

empty

Intervention groups

1

Description
Patients in placebo group received 0.5% bupivacaine (10 mg) and 0.5 mL of normal saline without preservative (total volume 2.5 ml) for spinal anesthesia.
Category
Placebo

2

Description
Patients in intervention group 1 received 0.5% bupivacaine (10 mg) and dexmedetomidine 5 micrograms (Origin orion pharma Germany) (total volume 2.5 ml) for spinal anesthesia.
Category
Treatment - Drugs

3

Description
Patients in intervention group 2 received 0.5% bupivacaine (10 mg) and 10 mg of meperidine (total volume 2.5 ml) for spinal anesthesia.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Amir Zarghami
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr Seyd 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
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Amir Zarghami
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3235 7282
Fax
Email
zarghamiamir@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Simin Azemati
Position
Cardio-Anesthesilogist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71364774270
Fax
Email
azemati@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Zarghami
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
71937-11351
Phone
+98 71 3228 9620
Fax
Email
zarghamiamir@sums.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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