Determining the effect of nasal phenylephrine drops on the amount of bleeding in cleft palate surgery
Design
A clinical trial with the control group, with parallel groups, double-blind, randomized, on 36 patients. Randomization with the table of random numbers.
Settings and conduct
Sampling is performed in Hazrat Fatemeh Hospital of Iran University of Medical Sciences. Patients are all placed under general anesthesia, then endotracheal intubation is performed and isoflurane and N2O are used to maintain anesthesia. Patients are operated on by a surgeon at the same time interval. In the intervention group, two drops of phenylephrine 0.25% are poured into each nose, and in the control group, the same amount of placebo is used. Then the amount of bleeding is done by calculating the volume of blood inside the suction and the number of blood gases, and the surgeon's satisfaction in terms of the quality of the operation site is assessed using the Likert and Boozart checklists. All necessary measures are taken to manage complications.
Participants/Inclusion and exclusion criteria
Children 6 months to 2 years old who are candidates for cleft palate surgery
Intervention groups
After induction of anesthesia, 2 drops of phenylephrine 0.25% In the intervention group and 2 drops of placebo in the control group are poured into each nostril.
Main outcome variables
Calculation of blood volume in suction, number of blood gases and their weight, surgeon's satisfaction in terms of quality of operation site and amount of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170301032837N4
Registration date:2021-05-12, 1400/02/22
Registration timing:prospective
Last update:2021-05-12, 1400/02/22
Update count:0
Registration date
2021-05-12, 1400/02/22
Registrant information
Name
Behrooz Zaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 7272
Email address
zaman.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of phenylephrine drops on the blood loss during and after reconstructive surgery of cleft palate in children
Public title
The effect of nasal phenylephrine drops on palatoplasty blood loss
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for cleft palate surgery
Age between 6 months to two years
Weight between 7 to 21 kg
Exclusion criteria:
Anemia
Cardiovascular disorders
Coagulopathies
Coagulopathies in Family
Any congenital and genetic disorders
Age
From 6 months old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, individual randomization using a table of random numbers, so that the first patient is placed in one of the two groups by lottery. The next patient will be placed in one of the two groups using a table of random numbers based on even and odd numbers, and this sequence will continue. The intervening researcher and evaluator are unaware of the random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who drops, the person who evaluates the bleeding, and the surgeon have no information. To prepare the placebo, empty a container of phenylephrine drops and fill it with distilled water instead. Make it in a form similar to phenylephrine drops and name solutions 1 and 2 and give it to the person who drops without knowing the type of solution.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-10-20, 1399/07/29
Ethics committee reference number
IR.IUMS.FMD.REC.1399.462
Health conditions studied
1
Description of health condition studied
Cleft palate
ICD-10 code
Q35
ICD-10 code description
Cleft palate
Primary outcomes
1
Description
Intraoperative blood loss
Timepoint
During the operation and the end of the operation
Method of measurement
Counting and weighing blood gases, blood in suctioning bottle
Secondary outcomes
1
Description
Surgeon satisfaction with the operation field
Timepoint
At the end of surgery
Method of measurement
Likert scale, Boozart scale
Intervention groups
1
Description
Intervention group:After induction of anesthesia and before the preparation of the operation, two drops of phenylephrine 0.25% are instilled in each nostril.
Category
Prevention
2
Description
Control group: After induction of anesthesia and before preparation, two drops of distilled water are instilled into each nostril from a container similar to a phenylephrine container.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-e Fatemeh Hospital
Full name of responsible person
Dr. Noor ahmad Latifi
Street address
21st. street. Assadabadi Ave.
City
Tehran
Province
Tehran
Postal code
1433933118
Phone
+98 21 8871 7272
Fax
+98 21 8810 7658
Email
crtfatima@iums.ac.ir
Web page address
https://crtfatima.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Abbas Motevalian
Street address
Shahid Hemmat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Fax
+98 21 8805 2248
Email
ivco@iums.ac.ir
Web page address
https://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Behrooz Zaman
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrate Fatemeh Hospital, 21 St, Asadabadi St, Tehran
City
Tehran
Province
Tehran
Postal code
1433933118
Phone
+98 21 8871 7272
Fax
+98 21 8871 5216
Email
zaman.b@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behrooz Zaman
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrate Fatemeh Hospital, 21 St, Asadabadi St, Tehran