Protocol summary

Summary
Ketamine is a safe an inexpensive drug and clinical experience shows that intravenous Ketamin can prevent intraoperative hypotension and stress and induce longer postoperative analgesia. In this study, we compared the hemodynamic and analgesic effects of low dose intravenous Ketamine + Midazolam and intravenous Midazolam alone, was given immediately after spinal anesthesia. 60 individuals aged 18 years and over with ASA (American Society for Anesthesiology) Class 1 or 2, were randomly assigned into two groups. Arterial pressures, heart rate values, adverse effects, the time of first request for postoperative analgesia, visual analogue pain scores, total analgesic consumptions at 24 h were recorded in all patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101293468N4
Registration date: 2011-04-04, 1390/01/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-04, 1390/01/15
Registrant information
Name
Mohammad Reza Hajiesmaeili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00983516227747-00983517232422
Email address
hajiesmaeili@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences and Health Services
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of hemodynamic effects of intravenous Ketamine after spinal anaesthesia for caesarean section
Public title
The investigation of hemodynamic effects of intravenous Ketamine after spinal anaesthesia for caesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- ASA=1,2; 2- No hx of recent head rrauma; 3- NO hx of opium addiction; 4- NO hx of psychiatric drug consumption; 5- NO hx of hallucination; 6- NO hx of delirium; 7- NO hx of hypertension; 8- NO hx of ischemic heart disease; 9-NO hx of known hypersensitivity to study drug; 10- Elective cesarean; 11- age above 18 years. Exclusion criteria: 1- hypersensitivity to study drug; 2- need to additive dose of Ketamine; 3- unexpected event during surgery.
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences and Health Services,
Street address
Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Postal code
Approval date
2009-08-20, 1388/05/29
Ethics committee reference number
1194

Health conditions studied

1

Description of health condition studied
anesthesia for cesarean delivery
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
hemodynamic variable
Timepoint
2 minute
Method of measurement
non invasive hemodynamic monitoring

Secondary outcomes

1

Description
post operative pain
Timepoint
1 hour
Method of measurement
VAS

Intervention groups

1

Description
Intervention group: Ketamine 30 milligram + 1 milligram midazolam = 2 milliliter intravenously
Category
Prevention

2

Description
Control group: 1 milligram midazolam = 2 CC
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Dr. Shekoufeh Behdad
Street address
Shahid Sadoughi hospital
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Hasssan Mozaffari
Street address
Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
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, Shahid Sadoughi University of Medical Sciences and Health Services
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
Shahid Sadoughi hospital
Full name of responsible person
Shekoufeh Behdad
Position
anesthesiology assistant professor
Other areas of specialty/work
Street address
Shahid Sadoughi hospital
City
Yazd
Postal code
Phone
+98 35 1822 1386
Fax
+98 35 1822 4100
Email
drbehdad@yahoo.com , hajiesmaeili@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science and Health Services
Full name of responsible person
Shekoufeh Behdad
Position
Anesthesiologisy assistant professor
Other areas of specialty/work
Street address
Shahid Sadoughi hospital
City
Yazd
Postal code
Phone
+98 35 1822 1386
Fax
+98 35 1822 4100
Email
drbehdad@yahoo.com , hajiesmaeili@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science and Health Services
Full name of responsible person
Mohammd Reza Haji Esmaeili
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Rahnemoon hospital
City
Yazd
Postal code
8919895746
Phone
+98 35 1625 8722
Fax
+98 35 1822 4100
Email
hajiesmaeili@ssu.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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