Protocol summary

Summary
After approval by the Ethics & Research committee of Hamadan University of Medical Sciences and obtaining written informed consent, 61 patients classified as ASA I (18–45 years) with gestational age 36-42 weeks who were scheduled for laboe under regional analgesia participated in this double blinded clinical trial. Patients were excluded for the following reasons: preeclampsia, chronic hypertension, diabetes,hepatic or renal disorders, allergy to drugs in the study, contraindication of neuraxial anesthesia,, mother addiction and drug abuse and any unexpected accident that need to cesarean section and privious history of pruritus or allergy to study drug . Before induction of spinal analgesia, baseline standard monitoring was recorded in a supine position by automatic monitoring (Novin S 1800, Saadat model). Spinal analgesia was administered by a 25 gauge Quincke needle (Mekon Medical devices Co. Shanghai China) at the L3-L4 inters pace, parallel to the dural fiber, while the patient was in the sitting position. Spinal analgesia consisted of 10 µg (2 ml) Sufentanil (Sufiject Aburaihan Co. Iran)administered in 12 sec. Patients were randomly allocated using opaque envelopes (block randomization with a block size of six) into three groups: groups1 and 2, in which the patients received 4mg ondansetron or 8 mg dexamethasone ,before induction of spinal analgesia, and group 0, in which the patients recieved normal salin as placebo. . To blinding the study, one anesthesiologist administered the spinal analgesia and randomized the patients, and another assistant performed drug preparation and injection. Systolic blood pressure (SBP), heart rate (HR), mean arterial blood pressure (MAP) and O2 saturation (SpO2) were recorded 1 min before (as baseline), and 5, 10, 15min after induction of analgesia, and there after in 15 minutes interval through the end of labor.scratching was observed and severity of pruritus was assessed by visual analogue scale of pruritus in above time intervals.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016052328010N1
Registration date: 2017-10-05, 1396/07/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-05, 1396/07/13
Registrant information
Name
Pouran Hajian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0312
Email address
hajian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2016-06-19, 1395/03/30
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between prophylactic effect of ondansetron versus dexamethason in reducing of opioid induced pruritus in labor analgesia with intratechal sufentanil
Public title
Prophylaxis of opioid induced pruritus in labor analgesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: parturient aged 18-45 and ASA I with gestational age 36-42 weeks that candidates for labor under regional analgesia. Exclusion criteria: preeclampsia; chronic hypertension; diabetes mellitus; allergy to drugs in the study; contraindication of neuraxial anesthesia; mother addiction and drug abuse and any unexpected accident that need for cesarean section; previous history of itching and allergy.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 63
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
Committee of Ethics in Research, Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
IR.UMSHA.REC.1395.421

Health conditions studied

1

Description of health condition studied
Intra echal Opioid Induced Pruritus
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery

Primary outcomes

1

Description
Intratechal opioid induced pruritus
Timepoint
just after spinal anesthesia, 5, 10, 15 min later then every 15 mint to 90 min
Method of measurement
Pruritus was asses by observe the scraching and by Visual Analouge Scale of pruritus every 5 Minute for 15 minute and every 15 mnutes untile 90 min

Secondary outcomes

1

Description
Other complication of spinal anesthesia: nausea & vomitting, hypotension
Timepoint
After spinal anesthesia untile the end of labor or to 90 min after spinal anesthesia
Method of measurement
Blood pressure was measured with automatic blood pressure device and hypotension was defined as more than 20% decrease of BP compared to baseline, and observation of any retching or explosion Of gastric content

Intervention groups

1

Description
Intervention 1: before performing intratechal opioid injection, 2cc Ondansetrone was injected intravenously
Category
Treatment - Drugs

2

Description
Control group: before performing intratechal opioid, 2cc disttiled water was injected intravenously
Category
Placebo

3

Description
Intervention 2: before prforming Iintra techal opioid injection, 2cc Dexamethasone was injected intravenously.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Pouran Hajian
Street address
Pasdaran Street, Shariati square
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences
Full name of responsible person
Saiid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmideh street, Hamadan
City
Hamadan
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 and Technology, Hamadan 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
Endometrium and Emdometriosis Research Center
Full name of responsible person
Pouran Hajian M.D
Position
Assistant Professor of Anesthsiology And Pain
Other areas of specialty/work
Street address
Anesthesiolgy Department, Besat hospital, Shahid Motahari Blvd, Resalat Square, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 3090
Fax
Email
hajian@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Endometrium and Endometriosis Research center & Hamadan University of Medical Sciences
Full name of responsible person
Pouran Hajian M.D
Position
Assistant Professor of Anesthsiology
Other areas of specialty/work
Street address
Anesthesiolgy Department, Besat hospital, Shahid Motahari Blvd, Resalat Square, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3264 0049
Fax
Email
hajian@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Endometrium and Emdometriosis Research Center,Hamadan,Hamadan University of Medical Sciences
Full name of responsible person
Pouran Hajian M.D
Position
Assisstant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiolgy Department, Besat hospital, Shahid Motahari Blvd, Resalat Square, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0312
Fax
Email
pooranhajian567@yahoo.com
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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