1- Objectives: Many of mothers need to do cesarean under general anesthesia. The main goal in this study is comparison of intubating conditions in remifentanil group versus succinylcholine group.
2- Design: Due to sux side effects investigators have searched to find a drug that has sux characters: "Remifentanil" an ultrshort opioid was used in number of studies in place of sux. It had not any bad effect even in 34 hours infusion before delivery.
3- Setting and conduct: We divide patients in two groups: Intervention group: For induction 1mic/kg remifentanil in 30 seconds and 5mg/kg thiopental in 10 seconds and N/S 5 cc are administered. After 1 min intubation is done. Control group or sux group: For induction 5mg/kg thiopental in 10 seconds and 1.5 mg/kg sux are administered. After 30 seconds intubation is done. Then we compare intubating conditions and APGAR in these two groups.
4- Participants including major eligibility criteria: Iranian pregnant females; ASA class1 and 2; 18-35 years old; BMI 18.5-24.9; without common cold; elective cesarean.
Mothers with difficult airway and ASA class 3 to 6; and fetal distress are excluded from study.
5- Intervention: Remifentanil is used instead of sux.
6- Main outcome measures variable: Intubating conditions and APGAR
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010612035N1
Registration date:2013-07-29, 1392/05/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-29, 1392/05/07
Registrant information
Name
Hamed Abdollahi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4422 6138
Email address
habdollahi@rocketmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of effect of succinylcholine and remifentanil on intubating conditions in elective cesarean section
Public title
Replacement of sux by remifentanil in intubation (GA) in cesarean
Purpose
Health service research
Inclusion/Exclusion criteria
Major inclusion criteria: Iranian pregnant female; ASA class1 and 2; 18-35 years old; BMI 18.5-24.9; without common cold; elective cesarean.
Major exclusion criteria: difficult airway; significant respiratory disease; severe asthma; GERD; neurologic and neuromuscular disease; cardiovascular disease; HTN; DM; allergy to drugs used in this study; organ failure; pregnancy intoxication; GDM; Placental abruption; oligo and polyhydramnious; placental abnormalities; coagulation and fetal abnormalities; opium and alcohol abuse.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahdan University of Medical Sciences
Street address
Pardis, Hesabi square, Zahedan
City
Zahedan
Postal code
98167-43463
Approval date
2012-08-14, 1391/05/24
Ethics committee reference number
91-932
Health conditions studied
1
Description of health condition studied
muscle relaxant in cesarean intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
intubation conditions
Timepoint
soon after intervention
Method of measurement
upon 5 Primary outcome is devided to 3 groups as well, intermediate and bad.
2
Description
APGAR
Timepoint
at min. 1 and 5 after delivery
Method of measurement
upon APGAR standard scale
Secondary outcomes
1
Description
jaw relaxation
Timepoint
soon after intervention
Method of measurement
upon numeric scale of jaw relaxation
2
Description
laryngoscopy
Timepoint
1 min. after intervention
Method of measurement
upon numeric scale of laryngoscopy
3
Description
vocal cords
Timepoint
1 min. after intervention
Method of measurement
upon numeric scale of vocal cords movement
4
Description
bucking after intubation
Timepoint
1 min after intervention
Method of measurement
upon numeric scale of bucking after intubation
5
Description
limbs movement
Timepoint
soon after intervention
Method of measurement
upon numeric scale of limbs movement after intubation
Intervention groups
1
Description
Intervention group: For induction 1mic/kg remifentanil in 30 seconds and 5mg/kg sodium thiopental in 10 seconds and N/S 5 cc are administered. After 1 min intubation is done.
Category
Treatment - Drugs
2
Description
Control group or sux group: For induction 5mg/kg thiopental in 10 seconds and 1.5 mg/kg sux are administered. After 30 seconds intubation is done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abitaleb hospital
Full name of responsible person
Hamed Abdollahi Murchekhorti
Street address
Khatam hospital, Khatam square, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Hamid Reza Mahmudzade Sagheb
Street address
Pardis, Hesabi square, Zahedan
City
zahedan
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, Zahedan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamed Abdollahi Murchekhort
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Khatam hospital, Khatam square, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1322 3001
Fax
Email
habdollahi@rocketmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamed Abdollahi Murchekhorti
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Khatam hospital, Khatam square, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1322 3001
Fax
Email
habdollahi@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)