Investigating the effect of aminophylline on the recovery time of hysterectomy patients under general anesthesia; A randomized double-blind clinical trial
Determining the effect of aminophylline on the recovery time of patients undergoing hysterectomy with general anesthesia
Design
A double-blinded and randomized clinical trial with parallel groups design of 74 patients
Settings and conduct
This study is conducted as a clinical trial in Alzahra Hospital in rasht.After explaining the purpose and method of the research, informed consent will be obtained.The patient will be in the supine position and standard monitoring will be established. Hydration will begin with normal saline.After pre-oxygenation with 100% oxygen, in case of stable hemodynamics and normal sinus rhythm, anesthesia induction will be performed.All patients will be operated by one anesthesiologist and one surgeon with the same method.5 minutes before the last suture, study drugs will be prepared in similar syringes by a technician who is not aware of the study and will be given to the anesthesia assistant.In this study, the anesthesiologist, the anesthesia assistant who records the data and patients are blind.Times of emergence, extubation and recovery will be calculated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidate for hysterectomy under general anesthesia in Alzahra hospital, ASA I, II. Exclusion criteria: hysterectomy due to malignancy, history of allergy to aminophylline,liver dysfunction, smokers, history of arrhythmia or neurological disorder such as epilepsy
Intervention groups
5 minutes before the surgeon`s last suture on the skin, patients in the intervention group will receive 3 milligrams per kilogram of intravenous aminophylline (manufactured by Caspian Tamin Pharmaceutical Company) diluted in 100 milliliters of normal saline and the control group will receive the same amount of normal saline.
Main outcome variables
Emergence time, extubation time, recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170314033069N5
Registration date:2022-12-31, 1401/10/10
Registration timing:prospective
Last update:2022-12-31, 1401/10/10
Update count:1
Registration date
2022-12-31, 1401/10/10
Registrant information
Name
Gelare Biazar Biazar
Name of organization / entity
Guilan University of Medical Sciences,Alzahra Hospital
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9024
Email address
biazar@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of aminophylline on the recovery time of hysterectomy patients under general anesthesia; A randomized double-blind clinical trial
Public title
The effect of aminophylline on the recovery time of hysterectomy patients under general anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists (ASA) I,II
Candidate for hysterectomy under general anesthesia in Alzahra hospital
Women aged 30 to 70
Exclusion criteria:
Hysterectomy due to malignancy
Any history of allergy to aminophylline or drug components
Any dysfunction of the liver, including liver cirrhosis, fatty liver, etc
smokers
People who have recently received or are taking cimetidine, ciprofloxacin, and macrolides such as erythromycin and clarithromycin
History of any type of arrhythmia or neurological disorder such as epilepsy
Patient dissatisfaction
Age
From 30 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to two groups A, aminophylline and B control by a random sequence created in blocks of four by WinPepi software, which was created by a statistical consultant and will be performed by a technician who is not aware of the goals of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be prepared in similar syringes by the anesthetic technician who is not aware of the goals of the study and will be provided to the anesthesia assistant. In this study, the anesthesiologist, the anesthesiology assistant who records the patient's information, and the patient are not able to recognize the received intervention, hence the study will be double-blind. In case of any complications, the anesthesiologist present in the operating room will be informed of the treatment groups to take the necessary actions.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht
City
Rasht
Province
Guilan
Postal code
4144654839
Approval date
2022-12-07, 1401/09/16
Ethics committee reference number
IR.GUMS.REC.1401.464
Health conditions studied
1
Description of health condition studied
Investigating the effect of aminophylline on the recovery time of patients after hysterectomy
ICD-10 code
O74
ICD-10 code description
Complications of anesthesia during labor and delivery
Primary outcomes
1
Description
Emergence from anesthesia
Timepoint
From the time of discontinuing administration of anesthetic drugs to the time of patient's eyes getting open after calling her/his name
Method of measurement
Time measurement
2
Description
Extubation time
Timepoint
From the time of discontinuing administration of anesthetic drugs to the time of removing the endotracheal tube
Method of measurement
Time measurement
3
Description
Recovery time
Timepoint
From the time of discontinuing administration of anesthetic drugs to the time of transferring the patient to the ward
Method of measurement
Time measurement
Secondary outcomes
1
Description
mean arterial blood pressure (MAP)
Timepoint
Before administration of aminophylline and normal saline and then every 5 minutes until transferring to recovery, then every 15 minutes during recovery
Method of measurement
Blood pressure measurement with mercury sphygmomanometer
2
Description
Heart rate
Timepoint
Before administration of aminophylline and normal saline and then every 5 minutes until transferring to recovery, then every 15 minutes during recovery
Method of measurement
Heart rate monitor
Intervention groups
1
Description
Intervention group: 5 minutes before the surgeon`s last suture on the skin, patients in the intervention group will receive 3 milligrams per kilogram of intravenous aminophylline (manufactured by Caspian Tamin Pharmaceutical Company) diluted in 100 milliliters of normal saline. The infusion will last for 10 minutes.
Category
Treatment - Surgery
2
Description
Control group: 5 minutes before the surgeon`s last suture on the skin, patients in the control group will receive 100 milliliters of normal saline. The infusion will last for 10 minutes.