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Evaluation of a Correlation between the Time of Low Dose Fentanyl Injection and Hemodynamic Responses during Tracheal Intubation in Emam Khomeini Hospital

Protocol summary

Summary
This clinical trial was conducted to evaluate optimal time of injection of a small dose of fentanyl during anesthetic induction to attenuate circulatory responses to laryngoscopy and tracheal intubation. A total of 120 patients who scheduled for elective surgery were included in this study. The patients were randomly allocated to five groups. In groups II, III, IV, and V, the patients received fentanyl (2 microg/kg), 1, 3, 5, and 10 min before tracheal intubation, respectively. Group I patients did not receive fentanyl and served as the control group. Following induction with thiopental and atracorium an oral tracheal intubation was accomplished in each patient. Pulse rate, systolic, diastolic blood pressure, and mean arterial blood pressure were measured before the induction and 1 min after the intubation and changes were compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012215363N2
Registration date: 2011-02-13, 1389/11/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-02-13, 1389/11/24
Registrant information
Name
Taraneh Naghibi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2865
Email address
tnaghibi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2006-04-21, 1385/02/01
Expected recruitment end date
2007-04-21, 1386/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of a Correlation between the Time of Low Dose Fentanyl Injection and Hemodynamic Responses during Tracheal Intubation in Emam Khomeini Hospital
Public title
Evaluation of a Correlation between the Time of Low Dose Fentanyl Injection and Hemodynamic Responses during Tracheal Intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I or II, Age between 20- 65 year, scheduled to undergo elective surgery under general anesthesia Exclusion criteria: any history of hypertension, intestinal obstruction, cachexia, dehydration; cardiac, coronary, neurological, respiratory or renal dysfunction; Patients with difficult intubation
Age
From 20 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Tehran University of Medical Sciences
Street address
Faculty of medicine, Tehran University of Medical Sciences, Enghelab Sq, Tehran, Iran
City
Tehran
Postal code
Approval date
2006-02-23, 1384/12/04
Ethics committee reference number
841207

Health conditions studied

1

Description of health condition studied
circulatory change after intubation
ICD-10 code
I97.9
ICD-10 code description
Postprocedural disorder of circulatory system, unspecified

Primary outcomes

1

Description
heart rate
Timepoint
before induction, 1 minute after intubation
Method of measurement
ECG

2

Description
systolic blood pressure
Timepoint
before induction, 1 minute after intubation
Method of measurement
NIBP

3

Description
diastolic blood pressure
Timepoint
before induction, 1 minute after intubation
Method of measurement
NIBP

4

Description
mean blood pressure
Timepoint
before induction, 1 minute after intubation
Method of measurement
NIBP

Secondary outcomes

empty

Intervention groups

1

Description
Group II: In this group patients received fentanyl (2 microg/kg) (Fentanyl – Janseen cilag - Belgium) 1min before tracheal intubation. Following induction with thiopental (5mg/kg) (Thiopental – SANDOZ - Austria) and atracorium (0.5mg/kg) (Atracurium 25– Aburahhan - Iran) an oral tracheal intubation was accomplished in each patient. Then they ventilated with 50% nitrous oxide, 50% oxygen and 0.8% halothane.
Category
Treatment - Drugs

2

Description
Group I (control): Following induction with thiopental (5mg/kg) (Thiopental – SANDOZ - Austria) and atracorium (0.5mg/kg) (Atracurium 25– Aburahhan - Iran) an oral tracheal intubation was accomplished in each patient, then they ventilated with 50% nitrous oxide, 50% oxygen and 0.8% halothane.
Category
Treatment - Drugs

3

Description
Group III: In this group patients received fentanyl (2 microg/kg) (Fentanyl – Janseen cilag - Belgium) 3min before tracheal intubation. Following induction with thiopental (5mg/kg) (Thiopental – SANDOZ - Austria) and atracorium (0.5mg/kg) (Atracurium 25– Aburahhan - Iran) an oral tracheal intubation was accomplished in each patient. Then they ventilated with 50% nitrous oxide, 50% oxygen and 0.8% halothane.
Category
Treatment - Drugs

4

Description
Group IV: In this group patients received fentanyl (2 microg/kg) (Fentanyl – Janseen cilag - Belgium) 5min before tracheal intubation. Following induction with thiopental (5mg/kg) (Thiopental – SANDOZ - Austria) and atracorium (0.5mg/kg) (Atracurium 25– Aburahhan - Iran) an oral tracheal intubation was accomplished in each patient. Then they ventilated with 50% nitrous oxide, 50% oxygen and 0.8% halothane.
Category
Treatment - Drugs

5

Description
Group V: In this group patients received fentanyl (2 microg/kg) (Fentanyl – Janseen cilag - Belgium) 10min before tracheal intubation. Following induction with thiopental (5mg/kg) (Thiopental – SANDOZ - Austria) and atracorium (0.5mg/kg) (Atracurium 25– Aburahhan - Iran) an oral tracheal intubation was accomplished in each patient. Then they ventilated with 50% nitrous oxide, 50% oxygen and 0.8% halothane.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice- Chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Dr Akhondzadeh
Street address
Rozbeh Hospital- Tehran- Iran
City
Tehran
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 of Tehran 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr Faramarz Dobakhti
Position
Phd, Assistant Professor
Other areas of specialty/work
Street address
Faculty of pharmacy- Zanjan University of Medical Sciences
City
Zanjan
Postal code
Phone
+98 982414273636
Fax
Email
fdobakhti@zums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan university of medical sciences
Full name of responsible person
Dr Taraneh Naghibi
Position
Assistant Professor - Anesthesiologist
Other areas of specialty/work
Street address
Ayatollah mosavi hospital- Zanjan- Iran
City
Zanjan
Postal code
Phone
+98 24 1424 2712
Fax
Email
tnaghibi@zums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Faramarz Dobakhti
Position
Assistant Professor
Other areas of specialty/work
Street address
school of pharmacy- Zanjan University of Medical Sciences
City
Zanjan
Postal code
Phone
Fax
Email
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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