Comparison of the effect of Intravenous Midazolam with Dexmedetomidine Infusion on Sedation and Duration of Spinal Anesthesia with Bupivacaine For Cesarean Section
Intravenous dexmedetomidine when used justr after spinal anaesthesia has many desirable effects such as adequate sedation, longer sensory-motor blockade, prolonged postoperative analgesia. The objectives of this study are to compare and evaluate the efficacy of intravenous dexmedetomidine premedication with midazolam on postoperative analgesia and sedation in patients undergoing cesarean section under bupivacaine spinal block. In this randomized double blind clinical trial, 70 ASA Class I/II patients with written informed consent, undergoing elective cesarean section under spinal anesthesia will divide into two groups of 35 each. In all patients subarachnoid block will perform with 3 ml of 0.5% hyperbaric bupivacaine, sensory and motor blockade will assesse. Immediately after umbilical cord clamping patients in group one will receive dexmedetomidine 1 μg/kg intravenously, whereas patients in group two will receive midazolam 0.03 mg/kg. The level of sedation will evaluate using Ramsay level of sedation scale intraoperatively and postoperatively every 15 mins. Blood pressure and heart rate will assess. The drugs will be prepared in covered syringes and will be injected blindly with an anesthesiologist who has performed the spinal block. Another person who is blinded to the drug injection will control intra and postoperative. Data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111410765N12
Registration date:2016-12-07, 1395/09/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-07, 1395/09/17
Registrant information
Name
Sousan Rasooli
Name of organization / entity
Alzahra hospital/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
rasoolis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center,Tabriz University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Intravenous Midazolam with Dexmedetomidine Infusion on Sedation and Duration of Spinal Anesthesia with Bupivacaine For Cesarean Section
Public title
Sedation and Duration of Spinal Anesthesia For Cesarean Section with IV Midazolam or Dexmedetomidine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Parturients candidate for elective cesarean section; ASA Class I & II;patients will give written informed consent
Exclusion criteria: Parturients with ASA Class III or higher; spinal anesthesia contraindications; Diabetics; preterm labor;hypertensive parturients; preeclampsia and eclampsia; hypotension; bradycardia; drug allergy; alcohol abuse; patients with cardiovascular; respiratory, renal; hepatic diesease َ
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:
70
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, Tabriz University of Medical Sciences
Street address
Golgasht Ave, Tabriz University of Medical Scienses,
City
Tabriz
Postal code
Approval date
2016-08-29, 1395/06/08
Ethics committee reference number
IR.TBZMED.REC.1395.570
Health conditions studied
1
Description of health condition studied
Adverse effect of drug
ICD-10 code
T88.9
ICD-10 code description
Complication of surgical and medical care, unspecified
Primary outcomes
1
Description
Sedation
Timepoint
During surgery and ricovery
Method of measurement
Ramsay sedation score (0-6)
Secondary outcomes
1
Description
Blood pressure
Timepoint
During surgery and recovery
Method of measurement
Non invasive
Intervention groups
1
Description
Intervention Group: The patients will be received 1 μg/kg of dexmedetomidine in 20 cc normal saline intravenously by over 10 min.
Category
Treatment - Drugs
2
Description
Patients will be received midazolam 0.03 mg/kg intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Obstetric and Gynecologic Hospital
Full name of responsible person
Sousan Rasouli
Street address
Al-Zahra Hospital, Sought Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elahe Madarek
Street address
Vice Chancellor for Research, Building No. 2 Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Reaserch center, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street
City
Tabriz
Postal code
Phone
+98 415539161
Fax
Email
Rasooli_s@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reaserch Center, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
Rasooli_s@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reaserch center, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Position
professor of Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
Rasooli_s@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)