Evaluation of adding Dexmedetomidine to the Patient-controlled intravenous analgesia pump (PCIA) on postoperative pain level in caesarean section surgery with spinal anesthesia
Evaluating the effect of adding dexmedetomidine drug to intravenous pain control pump on pain level after caesarean section surgery with spinal anesthesia
Design
Clinical trial with control and intervention group, with parallel groups, single-blind, randomized, phase 3 on 50 patients, random number table was used for randomization.
Settings and conduct
Patients referred to affiliated hospitals of Islamic Azad University of Tehran for cesarean section surgery with spinal anesthesia receive the interventions in a single-blind way and in two groups of 25 people.
Participants/Inclusion and exclusion criteria
Entry Criteria:
Volunteer for caesarean section surgery with spinal anesthesia in anesthesia classes 1ASA and 2ASA Referees of affiliated hospitals of Tehran Azad University of Medical Sciences
Exit Criteria:
The patient's lack of consent to participate in the study History of drug sensitivity to the drugs used Complications of anesthesia and surgery
Intervention groups
The intervention group receives routine pain control intravenous pump drugs (morphine, Apotel, dexamethasone and ondansetron) + dexmedetomidine.
The control group only received routine intravenous pain control drugs (morphine, Apotel, dexamethasone, and ondansetron).
Main outcome variables
Pain Level
Dexmedetomidine
Age
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230919059468N1
Registration date:2024-05-09, 1403/02/20
Registration timing:registered_while_recruiting
Last update:2024-05-09, 1403/02/20
Update count:0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Fateme Zabeti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3332 5251
Email address
fateme.zbt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-06, 1403/01/18
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adding Dexmedetomidine to the Patient-controlled intravenous analgesia pump (PCIA) on postoperative pain level in caesarean section surgery with spinal anesthesia
Public title
Dexmedetomidine in PCIA for Caesarean Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteer for caesarean section surgery with spinal anesthesia in anesthesia class ASA1 and ASA 2
Referees of affiliated hospitals of Tehran Azad University of Medical Sciences
Exclusion criteria:
The patient's lack of consent to participate in the study
History of drug sensitivity to the drugs used
Complications of anesthesia and surgery
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Simple Randomization
Randomization Unit: Individual
Randomization tool: Table of random numbers
Random sequence generation: Online Randomization
Allocation Concealment: Sequentially numbered, sealed, opaque envelopes
Randomization was done by simple randomization method with individual unit by random number table tool. The random sequence was generated by web tools (www.Randomization.com). The method of concealing the random allocation was the use of opaque and sealed envelopes with a random sequence. first, a number of envelopes with aluminum foil (in order to make the contents of the envelopes unclear) was prepared, and each of the random sequences created is recorded on a card and the cards placed in the letter envelopes are placed in order. At the time of starting the registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes will be opened in order and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient receives the drug (intervention or comparison group) in sealed envelopes that are coded. Coding is done by the researcher. The study is single-blinded and only the patient is blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran Azad University of Medical Science
Street address
Shariati Street, Khaghani Street, Tehran Islamic Azad University of Medical Science
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2023-09-12, 1402/06/21
Ethics committee reference number
IR.IAU.TMU.REC.1402.161
Health conditions studied
1
Description of health condition studied
Pain after caesarean section - pain after spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain level based on VAS criteria
Timepoint
6,12 and 18 hours after surgery
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
The amount of pethidine in people with moderate and severe VAS scores
Timepoint
6,12 and 18 hours after surgery
Method of measurement
Based on the dosage
Intervention groups
1
Description
Intervention group: Routine pain control intravenous pump drugs containing morphine (10mg), Apotel (1g), dexamethasone ampoule (8mg) and one ondansetron ampoule, along with the addition of 200 micrograms of dexmedetomidine
Category
Rehabilitation
2
Description
Control group: Routine pain control intravenous pump drugs containing morphine (10mg), Apotel (1g), dexamethasone ampoule (8mg) and one ondansetron ampoule
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr. Heidar Darvishi
Street address
Amiralmomenin Hospital, next to Sardar Jangal Park, Shirmohammadi Street, Naziabad
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
amhos@iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Masoud Parsania
Street address
Tehran, Dr. Shariati St., Amir Pabarja St., Ayene Blvd., Corner of Gol Yakh St., Headquarters Building of Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2264 0599
Email
Mparsania@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr. Heidar Darvishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran - Naziabad - Shahid Shirmohammadi St. - in front of Sardar Jangal Park - Amirul Mominin (A.S.) Hospital
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
dr_hdarvishi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Heidar Darvishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran - Naziabad - Shahid Shirmohammadi St. - in front of Sardar Jangal Park - Amirul Mominin (A.S.) Hospital
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
1811694784
Email
dr_hdarvishi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Zabeti
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Tehran - Naziabad - Shahid Shirmohammadi St. - in front of SardarJangal Park - Amirul Mominin (A.S.) Hospital
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
Fateme.zbt@gmail.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
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