Protocol summary
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Study aim
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Determining the effect of aminophylline on the recovery time of patients undergoing hysterectomy with general anesthesia
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Design
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A double-blinded and randomized clinical trial with parallel groups design of 74 patients.
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Settings and conduct
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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.After uterus removal by the surgeon, 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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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After uterus removal by the surgeon, 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 in 15 minutes.
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Main outcome variables
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Emergence time, extubation time, recovery time
General information
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Reason for update
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The dose and duration of injection of the intervention drug were accidentally entered incorrectly, which got corrected in the updated version.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170314033069N5
Registration date:
2022-12-31, 1401/10/10
Registration timing:
prospective
Last update:
2023-01-09, 1401/10/19
Update count:
1
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Registration date
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2022-12-31, 1401/10/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-01-20, 1401/10/30
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Expected recruitment end date
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2024-03-19, 1402/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of aminophylline on the recovery time of hysterectomy patients under general anesthesia; A randomized double-blind clinical trial
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Public title
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The effect of aminophylline on the recovery time of hysterectomy patients under general anesthesia
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 30 years old to 70 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
74
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-12-07, 1401/09/16
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Ethics committee reference number
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IR.GUMS.REC.1401.464
Health conditions studied
1
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Description of health condition studied
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Investigating the effect of aminophylline on the recovery time of patients after hysterectomy
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ICD-10 code
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O74
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ICD-10 code description
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Complications of anesthesia during labor and delivery
Primary outcomes
1
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Description
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Emergence from anesthesia
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Timepoint
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From the time of discontinuing administration of anesthetic drugs to the time of patient's eyes getting open after calling her/his name
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Method of measurement
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Time measurement
2
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Description
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Extubation time
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Timepoint
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From the time of discontinuing administration of anesthetic drugs to the time of removing the endotracheal tube
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Method of measurement
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Time measurement
3
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Description
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Recovery time
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Timepoint
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From the time of discontinuing administration of anesthetic drugs to the time of transferring the patient to the ward
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Method of measurement
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Time measurement
Secondary outcomes
1
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Description
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mean arterial blood pressure (MAP)
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Timepoint
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Before administration of aminophylline and normal saline and then every 5 minutes until transferring to recovery, then every 15 minutes during recovery
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Method of measurement
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Blood pressure measurement with mercury sphygmomanometer
2
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Description
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Heart rate
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Timepoint
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Before administration of aminophylline and normal saline and then every 5 minutes until transferring to recovery, then every 15 minutes during recovery
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Method of measurement
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Heart rate monitor
Intervention groups
1
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Description
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Intervention group: After uterus removal by the surgeon, 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 15 minutes.
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Category
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Treatment - Surgery
2
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Description
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Control group: After uterus removal by the surgeon, patients in the control group will receive 100 milliliters of normal saline. The infusion will last for 15 minutes.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Rasht University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available