Protocol summary

Summary
The overall goal: Comparison of therapeutic effect of intravenous ketamine low doses versus pethidine on post spinal anesthesia shivering in patients undergoing elective cesarean section. Study design: random double blind Placebo controlled. Study population: the study population consisted of patients who were referred for elective cesarean Best Hospital operating room. Inclusion Criteria: being candidate for cesarean section; fill in consent forms; physical status class I or II in accordance with anesthesia. Exclusion Criteria: pregnancy associated with diseases such as hypertension, diabetes; heart valve disease; coronary artery disease; pulmonary hypertension;pre Eclampsia and Diabetes mellitus. Sample size and sampling: with respect to Type I error of 5%, power of 90%, 45%, and the incidence of shivering in a group of 25 patients in the placebo group versus 85% in this study, 45 patients in each group were calculated for each group examines Intervention or interventions studied: Pethidine group of 5/0 3 kg and ketamine / kg in a volume equal to 0 immediately after spinal anesthesia is injected intravenously. Presence or absence of chills and grade them 4-0 is determined based on.Grade zero: no chills. Grade1: mild fasciculation in the face and neck. Grade2: trembling visible muscle groups in more than one category. Grade 3: Zlany activity of the whole body is involved. Intervention: the drug intravenously then Immediately after injection of spinal anesthetic is injected. Then chill after surgery to assess patient access to measures of pain occurs. Primary outcome or outcomes studied: during surgery and recovery Any adverse effect if seen is recorded Adverse events (nausea, vomiting, nystagmus, hypotension requiring treatment, bradycardia requiring medication).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013100214860N1
Registration date: 2013-10-25, 1392/08/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-25, 1392/08/03
Registrant information
Name
Arman Sarshivi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1356 4240
Email address
arman.sarshivi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Office of Kurdistan University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of intravenous ketamine low doses versus pethidine on post spinal anesthesia shivering in patients undergoing elective cesarean section
Public title
Davy effects of pethidine and ketamine in preventing postoperative shivering after cesarean section in pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: being candidate for cesarean section; fill in consent forms; physical status class I or II in accordance with anesthesia. Exclusion Criteria: pregnancy associated with diseases such as hypertension, diabetes; heart valve disease; coronary artery disease; pulmonary hypertension;pre Eclampsia and Diabetes mellitus.
Age
No age limit
Gender
Female
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
Not used
Assignment
Parallel
Other design features
Informed consent was obtained from patients undergoing elective cesarean section patients are being enrolled. Vblafaslh drug intravenously after spinal injection is administered. Presence or absence of chills and grade will be determined based on a 4-0 scale.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Opposite Hotel Shadi, Campus
City
sanandaj
Postal code
66177-13446
Approval date
2013-08-06, 1392/05/15
Ethics committee reference number
MUK.REC.1392.10

Health conditions studied

1

Description of health condition studied
Shivering after spinal anesthesia in patients undergoing elective cesarean surgery.
ICD-10 code
074.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery

Primary outcomes

1

Description
Shivering after spinal anesthesia in patients undergoing elective cesarean
Timepoint
Since spinal anesthesia or intravenous pethidine or ketamine
Method of measurement
Presence or absence of chills and grade them 4-0 is determined based on.Grade zero: no chills. Grade1: mild fasciculation in the face and neck. Grade2: trembling visible muscle groups in more than one category. Grade 3: Zlany activity of the whole body is involved.

Secondary outcomes

1

Description
Adverse events (nausea, vomiting, nystagmus, hypotension requiring treatment, bradycardia requiring medication
Timepoint
Any complications during the surgery and recovery if the questionnaire is
Method of measurement
Based on history and physical examination and observation

Intervention groups

1

Description
Pethidine group of 0/5 kg ketamine group and 0/3 kg at equal volume immediately after spinal anesthesia is injected intravenously. Two groups of disposable needles for anesthetic drug bupivacaine 24 and 12 mg dose is used.
Category
Treatment - Drugs

2

Description
In control group, 24 disposable needles for anesthetic drug bupivacaine and 12 mg dose is used unlike the intervention group but no drug (ketamine or pethidine) for prevention of shivering after cesarean section are not receiving.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Dr. karim naseri
Street address
Vakili cross road
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Office of Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Ataolah Haydari
Street address
Kurdistan University of Medical Sciences
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Office of Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Arman Sarshivi
Position
Medical Student
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 1356 4240
Fax
Email
armansarshivi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr.Karim Naseri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 1666 4654
Fax
Email
bihoshi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Arman Sarshivi
Position
Medical Student
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
666177-13446
Phone
+98 87 1356 4240
Fax
Email
armansarshivi@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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