Protocol summary
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Study aim
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Comparison of the effect of remifentanil and dexmedetomidine on surgeon satisfaction from surgical field and bleeding in rhinoplasty
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Design
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Double-blind randomized clinical trial
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Settings and conduct
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The drugs are prepared in the operating room by a nurse who is unaware of the type of study with label A in the dexmedetomidine group and label B in the remifentanil group and are given to a person who is unaware of the specialization of the groups for injection. The person assessing patients and patient satisfaction at the end of the study is also unaware of the allocation of study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:18-45 y/o, Patients undergoing rhinoplasty surgery
Exclusion criteria: Patients with liver dysfunction, Renal dysfunction, Any known allergy or hypersensitivity to study drugs, analgesics abuse, opium addiction, Diabetes , Hemorrhagic disease, Using anticoagulants, Cerebrovascular disease, Heart block, Cardiovascular disease.
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Intervention groups
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In the Intervention group one patients will receive 1 μg / kg dexmedetomidine (PFIZER, USA) for 20 minutes and at the same time as induction begins with a dose of 0.6 μg / kg and continues until the end of the operation.
In the Intervention group two simultaneously with the induction of anesthesia, in the remifentanil group (EXIR, IRAN), remifentanil infusion of 0.25 μg is started. It continued until the end of the operation.
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Main outcome variables
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Intraoperative bleeding, pain,surgeon satisfaction
General information
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Reason for update
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A more accurate record of the study method
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141009019470N112
Registration date:
2021-04-01, 1400/01/12
Registration timing:
prospective
Last update:
2021-07-11, 1400/04/20
Update count:
1
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Registration date
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2021-04-01, 1400/01/12
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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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2021-04-23, 1400/02/03
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Expected recruitment end date
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2021-06-24, 1400/04/03
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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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Comparison of the effect of remifentanil and dexmedetomidine on surgeon satisfaction from surgical field and bleeding in rhinoplasty
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Public title
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Comparison of the effect of remifentanil and dexmedetomidine on surgeon satisfaction from surgical field and bleeding in rhinoplasty
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
18-45 years old
Patients undergoing rhinoplasty surgery
time of surgery is 7-10 days before menstruation time
Exclusion criteria:
Patients with liver dysfunction
Renal dysfunction
Any known allergy or hypersensitivity to study drugs
Abuse of analgesics and any addiction to opioid,
Diabetes mellitus
Hemorrhagic disease
Using anticoagulants
Cerebrovascular disease
Heart block
Cardiovascular disease
Morbid obesity
Females whom experience nausea and vomiting in their menstrual cycle
Revision rhinoplasty surgery
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Age
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From 18 years old to 45 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method is based on permutation block randomization method with block size 6 by using the site www.sealedenvelope.com and Seed number: 266608829014794.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The drugs are prepared by a nurse who is unaware of the type of study with label A in the dexmedetomidine group and label B in the remifentanil group and are given to a person who is unaware of the specialization of the groups for injection. The person assessing patients and patient satisfaction at the end of the study is also unaware of the allocation of study groups.
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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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2020-07-19, 1399/04/29
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Ethics committee reference number
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IR.SUMS.MED.REC.1399.241
Health conditions studied
1
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Description of health condition studied
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Rhinoplasty surgery
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ICD-10 code
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Z41.1
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ICD-10 code description
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Encounter for cosmetic surgery
Primary outcomes
1
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Description
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Amount of intraoperative bleeding
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Timepoint
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At the end of the surgery
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Method of measurement
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Observasion
2
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Description
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Post operative pain
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Timepoint
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At arrival to the recovery room and at, 45,30,15 minutes
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Method of measurement
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Visual analogue Scale
Secondary outcomes
1
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Description
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Patients’ satisfactions
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Timepoint
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After injection of intervention drugs in the recovery room and surgery ward
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Method of measurement
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Likert Scale
2
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Description
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Surgeon’ satisfactions
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Timepoint
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At the end of the surgery
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Method of measurement
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Likert Scale
Intervention groups
1
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Description
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Intervention group: In the Intervention group one patients will receive 1 μg / kg dexmedetomidine (PFIZER, USA) for 20 minutes and at the same time as induction begins with a dose of 0.6 μg / kg and continues until the end of the operation..
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Category
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Prevention
2
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Description
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Intervention group: In the Intervention group two:Simultaneously with the induction of anesthesia, in the remifentanil group (EXIR, IRAN), remifentanil infusion of 0.25 μg is started. It continued until the end of the operation.
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Category
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Prevention
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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Shiraz 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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It is against the policies of the center.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available