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Comparison the hemodynamic responses to laryngoscopy and tracheal intubation with glidescope or Macintosh laryngoscope in severe preeclamptic patients undergoing cesarean delivery

Protocol summary

Study aim
Comparison of the hemodynamic responses including blood pressure changes, heart rate, and heart rhythm in the two laryngoscopy techniques of glideoscope and Macintosh
Design
A clinical trial in two groups of study and control group, with parallel groups, single blind, randomized
Settings and conduct
In Tabriz Alzahra Hospital , 70 pregnant women were randomly assigned to two groups of 35 subjects, using Randlist online software. In the study group, the intubation was performed with a glidescope and in the control group with a Macintosh laryngoscope. In this study, patients were blinded to intubation method.
Participants/Inclusion and exclusion criteria
Include criteria: Women aged 18 to 40 years old with a term ( more than 37-weeks) pregnancy with severe pre-eclampsia with Mallampati degree1 and 2 who are candidates for cesarean section and have Informed consent to enter the study. Exclude criteria: Twins pregnancy, Body mass index (BMI) greater than 30, Higher Mallampathi grade, Maternal diseases, The recent use of vasoactive, Cervical movement limitation, Coagulation disorder, Eclampsy.
Intervention groups
Patients were randomly divided into two groups of 35 subjects. After general anesthesia, in the study group, intubation is performed with a glidescope and in the control group with a Macintosh laryngoscope.
Main outcome variables
Blood pressure changes; Heart rate changes; Cardiac rhythm changes; Number of attempts to intubate; The time of intubation; Postoperative side effects of tracheal intubation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110712007013N20
Registration date: 2018-10-16, 1397/07/24
Registration timing: retrospective

Last update: 2018-10-16, 1397/07/24
Update count: 0
Registration date
2018-10-16, 1397/07/24
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the hemodynamic responses to laryngoscopy and tracheal intubation with glidescope or Macintosh laryngoscope in severe preeclamptic patients undergoing cesarean delivery
Public title
Comparison of the hemodynamic responses in tracheal intubation with glidescope or Macintosh in severe preeclampsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term pregnant women Age range 18-40 years old Candidates for elective or urgent cesarean section Severe preeclampsia Mallampati score I or II in preoperative visit informed consent
Exclusion criteria:
Mallampati score III or IV in preoperative visit Maternal co-existing disease History of cervical spine deformity or cervical motion limitation Eclampsia Coagulation disorder Body mass index (BMI) >30kg/m2 Recent use of vasoactive drugs
Age
From 18 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
  • Participant
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups by Randlist online software
Blinding (investigator's opinion)
Single blinded
Blinding description
Single Blinded All patients participating in this study are blind to the type of laryngoscopy with a glidescope or Macintosh.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Department of Anesthesiology, Alzahra hospital, South artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5174815811
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.TBZMED.REC.1397.048

Health conditions studied

1

Description of health condition studied
Severe preeclampsia
ICD-10 code
O14.1
ICD-10 code description
Severe pre-eclampsia

Primary outcomes

1

Description
Hemodynamic responses to laryngoscopy with Glidescope(Non-invasive blood pressure (systolic, diastolic and mean arterial), heart rate and heart rhythm of the mother)
Timepoint
Before induction of anesthesia (basic values), 30 seconds after administration of induction drugs, 15 seconds after the start of laryngoscopy, and then every 1 minute to 5 minutes after the tracheal intubation
Method of measurement
Non-invasive blood pressure (systolic, diastolic and mean arterial), heart rate, and heart rhythm are measured using the Datex Ohmeda S / 5 Anesthesia Machine and will be recorded in the checklist for this purpose.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After 3 minutes preoxygenation with 100% O2 , general anesthesia is induced by Rapid sequence induction. After 60 seconds, the intubation is done by the Glidescope® videolaryngoscope [GVL, (Glidescope®, Saturn Biomedical Systems Inc., Canada)]and the tracheal tube inserted.
Category
Treatment - Devices

2

Description
Control group:After 3 minutes preoxygenation with 100% O2 , general anesthesia is induced by Rapid sequence induction. After 60 seconds, the intubation is done by the laryngoscope of the Macintosh blade 3 and the tracheal tube inserted. Intubation is performed by a fix anesthetist with more than 50 intubations history.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Simin Atashkhoyi
Street address
Alzahra hospital, South artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9163
Email
alzahrahosp@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Jouyban
Street address
No 2 Central Building, International Relations Office, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Simin Atashkhoyi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra Hospital, South Artesh Street
City
Tabriz
Province
East Azarbaijan
Postal code
5174815811
Phone
+98 41 3553 9163
Email
re.abri@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Simin Atashkhoyi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operating room-alzahra hospital- south artesh st
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3476 7121
Email
atashkhoii@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Simin Atashkhoyi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operating room-alzahra hospital- south artesh st
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3476 7121
Fax
Email
atashkhoii@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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