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Comparing the effect of two different doses of dexmedetomidine and propofol in sedation during surgery; Hemodynamic changes and postoperative complications in patients undergoing ovarian puncture surgery

Protocol summary

Study aim
Determining and comparing the effect of two different doses of dexmedetomidine and propofol in sedation during surgery in patients undergoing ovarian puncture surgery
Design
A randomized, triple-blinding clinical trial, with the parallel groups, Phase 3 on 96 patients
Settings and conduct
In this three-blind randomized clinical trial study, 96 eligible patients referred to Isfahan Shahid Beheshti Hospital will be included and will be randomly divided into three groups. For patients in three groups, dexmedetomidine 0.5 and 1 μg/kg and propofol 50 μg/kg will be prescribed respectively. In this study, the patient, the researcher, and the statistical analyst will have no knowledge of the type of intervention. Then the degree of sedation and hemodynamic parameters of the patients will be evaluated between the three groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria include infertile women candidates for puncture operation with IVF/ICSI indication, in the age group of 25 to 43 years, with ASA I or II, consent to enter the study. Exclusion criteria include having an allergy to any drug used, having a history of comorbidity.
Intervention groups
Control group: in this group, propofol induction of anesthesia 50 μg/kg per minute is prescribed. First intervention group: In this group, dexmedetomidine bolus dose of 0.5 μg/kg is prescribed for induction of anesthesia, and dexmedetomidine dose of 0.5 μg/kg per minute is prescribed for anesthesia maintenance. The second intervention group: In this group, a bolus dose of dexmedetomidine 1 μg/kg is prescribed for induction of anesthesia, and a dose of dexmedetomidine 1 μg/kg per minute is prescribed for anesthesia maintenance.
Main outcome variables
Heart rate; Systolic blood pressure; Diastolic blood pressure; Respiratory rate; Percentage of oxygen saturation; Degree of sedation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N73
Registration date: 2024-02-16, 1402/11/27
Registration timing: prospective

Last update: 2024-02-16, 1402/11/27
Update count: 0
Registration date
2024-02-16, 1402/11/27
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of two different doses of dexmedetomidine and propofol in sedation during surgery; Hemodynamic changes and postoperative complications in patients undergoing ovarian puncture surgery
Public title
Comparison of the effects of two different doses of dexmedomidine and propofol in sedation during ovarian surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women candidates for puncture operation with IVF/ICSI indication Age 25 to 43 years With ASA I or II Consent to enter the study
Exclusion criteria:
Having an allergy to any drug used Having a history of diseases such as epilepsy and gastric reflux and a history of severe cardiovascular disease and the presence of atrial block or stroke
Age
From 25 years old to 43 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 96 eligible patients are randomly selected. For this, the letter A is written on 32 sheets, the letter B is written on 32 sheets, the letter C is written on 32 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to achieve the triple-blind study, different doses of dexmedomidine and propofol will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A, B, and C. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2023-12-27, 1402/10/06
Ethics committee reference number
IR.MUI.MED.REC.1402.362

Health conditions studied

1

Description of health condition studied
Ovarian puncture surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sedation
Timepoint
Before the intervention and then 5, 10, 15 and 30 minutes after the intervention and then every 15 minutes during recovery until discharge
Method of measurement
Richmond sedation score scale (RASS) as a score of +4 to -5

2

Description
Hear rate
Timepoint
Before the intervention and then 5, 10, 15 and 30 minutes after the intervention and then every 15 minutes during recovery until discharge
Method of measurement
Monitoring device

3

Description
Diastolic blood pressure
Timepoint
Before the intervention and then 5, 10, 15 and 30 minutes after the intervention and then every 15 minutes during recovery until discharge
Method of measurement
Monitoring device

4

Description
Systolic blood pressure
Timepoint
Before the intervention and then 5, 10, 15 and 30 minutes after the intervention and then every 15 minutes during recovery until discharge
Method of measurement
Monitoring device

Secondary outcomes

empty

Intervention groups

1

Description
Control group: in this group, propofol induction of anesthesia 50 μg/kg per minute is prescribed.
Category
Treatment - Drugs

2

Description
First intervention group: In this group, dexmedetomidine bolus dose of 0.5 μg/kg is prescribed for induction of anesthesia, and dexmedetomidine dose of 0.5 μg/kg per minute is prescribed for anesthesia maintenance.
Category
Treatment - Drugs

3

Description
The second intervention group: In this group, a bolus dose of dexmedetomidine 1 μg/kg is prescribed for induction of anesthesia, and a dose of dexmedetomidine 1 μg/kg per minute is prescribed for anesthesia maintenance.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohammadreza Habibzadeh
Street address
Motahari Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
M.habibzadeh@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
M.habibzadeh@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
M.habibzadeh@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Vazifeh Azadani
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
zv.azadani@ymail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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