Protocol summary

Study aim
To investigate the effects of Dexmedetomidine on post-operative pain in patients undergoing Total Abdominal Hysterectomy (TAH).
Design
Randomised, controlled, parallel group trial with blinded outcome assessment. Randomisation will be done with simple randomization with random number tables
Settings and conduct
Seventy patients in age group 35 to 65 years are randomly divided using random digits table into control and intervention groups (n=35 cases). Researchers responsible for data collection and analyses are blind to the groups allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria are female patients (range age 35-65 years) candidate of Total Abdominal Hysterectomy (TAH), Body mass index (BMI): 18 to 40 kg/m2, and the ASA class I , II; The exclusion criteria are allergic reaction to Dexmedetomidine, history of Dexmedetomidine administration over the past week, history of heart, lung, liver, and kidney diseases, patients with neurological or neuromuscular disorders, patients with anemia or bleeding disorders, consumption of Alcohol, narcotic and Antipsychotic medications, and patients with diabetes.
Intervention groups
Anesthesia is performed in all patients with the same drugs, including Midazolam (0.3 mg/kg), Fentanyl (3 mg/kg), Thiopental (5 mg/kg), Atracurium (0.5 mg/kg). In the Intervention group, immediately after the induction, Dexmedetomidine with a bolus dose of (1 μg/kg) is injected for 15 minutes and then infusion is done with a dose of (0.5 μg/kg) until the end of surgery. In the control group, immediately after the induction, normal saline with a dose of (1 μg/kg) is injected for 15 minutes and then infusion is done with a dose of (0.5 μg/kg) until the end of surgery.
Main outcome variables
The postoperative pain, mean arterial pressure and heart rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190222042805N1
Registration date: 2019-06-27, 1398/04/06
Registration timing: registered_while_recruiting

Last update: 2019-06-27, 1398/04/06
Update count: 0
Registration date
2019-06-27, 1398/04/06
Registrant information
Name
Negin Babadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 5935
Email address
babadi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intravenous Dexmedetomidine on Post-Operative Pain in Patients undergoing Total Abdominal Hysterectomy
Public title
Intravenous Dexmedetomidine on Post-Operative Pain in Patients Candidate of Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female candidate of Total Abdominal Hysterectomy (TAH) Age range 35–65 years Body mass index (BMI): 18 to 40 kg/m2 American Society of Anesthesiologists (ASA) classification I , II
Exclusion criteria:
Allergic reaction to Dexmedetomidine History of Dexmedetomidine administration over the past week History of heart, lung, liver, and kidney diseases Patients with neurological or neuromuscular disorders Patients with anemia or bleeding disorders Patients with anemia or bleeding disorders Consumption of Alcohol, narcotic and Antipsychotic medications Patients with diabetes
Age
From 35 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups based on simple randomization method using random digits table. In this method, a collection of non-template numbers is randomly generated and arranged as a table. Even numbers for the intervention group and the odd numbers for the control group are considered. According to the number of patients, they are randomly assigned to one of the treatment or intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Responsible for collecting data, data analyzer
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Research deputy, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.AJUMS.REC.1397.454

Health conditions studied

1

Description of health condition studied
Abdominal Hysterectomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Post-operative pain
Timepoint
1, 2, 4, 8, 16 and 24 hours after the completion of the surgical operation
Method of measurement
The Visual Analog Scale (VAS)

2

Description
Mean Arterial Pressure (MAP)
Timepoint
Before anesthesia induction (pre-intervention), after intubation, every 15 minutes until the end of the recovery period
Method of measurement
Gauge pressure

3

Description
Heart rate
Timepoint
Before anesthesia induction (pre-intervention), after intubation, every 15 minutes until the end of the recovery period
Method of measurement
Electrocardiograph signal

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Immediately after the induction, Dexmedetomidine with a bolus dose of (1 μg/kg) is injected for 15 minutes and then infusion is done with a dose of (0.5 μg/kg) until the end of surgery
Category
Treatment - Drugs

2

Description
Control group: Immediately after the induction, normal saline with a dose of (1 μg/kg) is injected for 15 minutes and then infusion is injected with a dose of (0.5 μg/kg) until the end of surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shole Nesioonpur
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 2925
Email
drnesioon@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
PAIN-9707
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Babadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
Babadi.Negin@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shole Nesioonpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61322235292
Email
nesioon@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Babadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
Babadi.Negin@yahoo.com

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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