Protocol summary

Summary
The overall goal: to determine the prevalence of shivering after spinal anesthesia for caesarean section in groups of midazolam, midazolam - ketamine and ketamine. Study design: Randomized, single-blind, placebo-controlled. The study population: consists of patients who were referred for elective cesarean section Fatemieh Hospital operating room in Hamadan City Inclusion criteria: (a) Age 18-40 years and undergoing cesarean section; (b) ; physical status class I or II in accordance with anesthesia; (c) Term pregnancy (gestational age 36-40 weeks); (d) Singleton pregnancy. Exclusion criteria: (a) High-risk pregnancy; (b) Preeclampsia;(c) A history of cardiovascular disease, lung disease, mental, thyroid disease, diabetes mellitus type 1 and 2;(d) needs to blood or blood supply transfusion;(e) Fever over 38 ° C;(f) Drag over an hour during surgery;(g) A history of nausea and vomiting to Previous surgery;(h) Patients with spinal anesthesia ban. The sample size:In this study, 31 patients in each group is examined. Intervention or interventions studied: Patients were randomly divided into four groups A Midazolam75 µg / kg, Group B ketamine 0/5mg / kg, Group C ketamine0/25 mg / kg + 37/5μg / kg midazolam and Group D (control group) received normal saline 9/0% divided. Drugs after clamping the umbilical cord is injected intravenously. Shivering will be evaluated by crosly scale and sedation score will be evaluated by Ramsay sedation scale. Primary outcome or outcomes studied: Side effects such as nausea and vomiting after surgery, Changes in blood pressure and heart rate, arterial oxygen saturation and hallucination will be reviewed and evaluated at the end of the above parameters.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016043012251N3
Registration date: 2016-05-21, 1395/03/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Nasim Alipour
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 312 6716
Email address
n.alipour@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effeect of intravenous injection of midazolam ,midazolam- ketamine and ketamine on reduce prevalence of post spainal sheivering in patients undergoing elective cesarean section
Public title
The effeect of intravenous injection of midazolam ,midazolam- ketamine and ketamine on reduce prevalence of post spainal sheivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) Age 18-40 years and undergoing cesarean section; (b) ; physical status class I or II in accordance with anesthesia; (c) Term pregnancy (gestational age 36-40 weeks); (d) Singleton pregnancy. Exclusion criteria: (a) High-risk pregnancy; (b) Preeclampsia;(c) A history of cardiovascular disease, lung disease, mental, thyroid disease, diabetes mellitus type 1 and 2;(d) needs to blood or blood supply transfusion;(e) Fever over 38 ° C;(f) Drag over an hour during surgery;(g) A history of nausea and vomiting to Previous surgery;(h) Despite the decrease in body temperature or sheivering before the start of anesthesia due to fear or other reasons;(i) Patients with spinal anesthesia ban.
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: 124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan
City
Hamadan
Postal code
6517838695
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
IR.UMSHA.REC.1395.2

Health conditions studied

1

Description of health condition studied
post spainal sheivering
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
Shivering after spinal anesthesia in patients undergoing elective cesarean
Timepoint
Since spinal anesthesia or intravenous of midazolam, ketamine ,midazolam- ketamine or normal saline
Method of measurement
Shivering intensity divided by 4 score will be assessed.Grade zero: no Shivering . 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
heart rate
Timepoint
during the surgery and recovery
Method of measurement
Cardiac monitor

2

Description
arterial blood oxygen saturation
Timepoint
during the surgery and recovery
Method of measurement
Pulse oximeter

3

Description
Hemodynamic instability
Timepoint
during the surgery and recovery
Method of measurement
Sphygmomanometer

4

Description
hallucination
Timepoint
during the surgery and recovery
Method of measurement
Observation

5

Description
Sedation Score
Timepoint
during the surgery and recovery
Method of measurement
Ramsay score

Intervention groups

1

Description
In First group, we will inject 75 µg /kg of Midazolam IV. after clamping the umbilical cord.
Category
Prevention

2

Description
In Second group, we will inject 0/5mg / kg of ketamine IV. after clamping the umbilical cord.
Category
Prevention

3

Description
In Third group, we will inject 0/25mg / kg of ketamine and 37/5μg / kg midazolam IV. after clamping the umbilical cord.
Category
Prevention

4

Description
In control group we will inject 2 cc of Normal saline 0/9% IV. after clamping the umbilical cord
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nasim Alipour
Street address
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
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 the 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
Fatemieh Hospital
Full name of responsible person
Nasim Alipour
Position
Master of Critical Care Nurses, Clinical instructor
Other areas of specialty/work
Street address
Fatemieh hospital,Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 31 3827 7012
Fax
Email
n.alipour@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr. Nahid Manouchehrian
Position
Associated professor of Anesthesia Department
Other areas of specialty/work
Street address
Fatemiyeh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 7012
Fax
Email
manuchehrian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Nasim Alipour
Position
Master of Critical Care Nurses, Clinical instructor
Other areas of specialty/work
Street address
City
Hamadan
Postal code
Phone
+98 81 3827 7012
Fax
Email
n.alipour@umsha.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
Loading...