Protocol summary
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Study aim
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Comparison of Hemodynamic Changes and Complications of Laryngeal Muscle Ligation (LMA) Intubation in Patients Undergoing Lumbar Disc Surgery
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Design
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In this single-blind randomized clinical trial, patients with ASA Class I, II aged 18-55 years who referred to the operating room of Kashan Shahid Beheshti Hospital for laminectomy in 1997-98,
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Settings and conduct
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Operating Room of Kashan Shahid Beheshti Hospital
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Participants/Inclusion and exclusion criteria
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Patients Referred to the Operating Room of Shahid Beheshti and Naghavi Hospitals of Kashan in 1398-1989 with ASA Class I, II, Inclusion Criteria for Lumbar Disc Surgery
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Intervention groups
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The intervention of this study is the airway device that will be one of the two endotracheal tube or laryngeal mask devices during anesthesia. Patients are randomly selected for the airway and patients are not aware of the type of airway used.
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Main outcome variables
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ASA class, age, sex, heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure (MAP), arterial blood oxygen saturation (SPO2), expired carbon dioxide (ETCO2), maxillary inspiratory pressure (PIP), sore throat, Intubation failure, noise and cough violence, laryngospasm, nausea and vomiting
General information
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Reason for update
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Change in the start and end date of sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191223045877N1
Registration date:
2020-01-01, 1398/10/11
Registration timing:
registered_while_recruiting
Last update:
2020-01-07, 1398/10/17
Update count:
1
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Registration date
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2020-01-01, 1398/10/11
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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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2019-10-23, 1398/08/01
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Expected recruitment end date
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2020-10-22, 1399/08/01
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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 hemodynamic changes and complications of endotracheal intubation with insertion of laryngeal mask airway(LMA) in patients undergoing lumbar disc surgery in prone position
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Public title
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hemodynamic changes and complications of endotracheal intubation with insertion of laryngeal mask airway(LMA)
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Purpose
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Diagnostic
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18 to 55 years
Candidate for lumbar disc surgery
Anesthesia risk in terms of ASA class I, II classification
NPO 6 to 8 hours
BMI greater than 18 and less than 30
Exclusion criteria:
Patients with a nasal-gastric tube
Patients with the possibility of difficult intubation
Patients with preoperative sore throat
Patients taking sedative and analgesic drugs
Uncontrolled diabetes and uncontrolled hypertension
No informed consent to participate in the study
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Age
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From 18 years old to 55 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients with ASA Class I, II who referred to the operating room of Kashan Shahid Beheshti Hospital for laminectomy were randomly assigned into two groups of 35 each.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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After patients enter the operating room and obtain consent to participate in the study and have a vein in a healthy hand and a Ringer's serum connection, the patient is completely blind to the study.
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Placebo
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Not 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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2019-10-21, 1398/07/29
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1398.082
Health conditions studied
1
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Description of health condition studied
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Patients undergoing lumbar disc surgery
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Comparison of hemodynamic changes and complications of intubation in patients undergoing lumbar disc surgery
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Timepoint
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2, 4, 6, 12 and 24 hours after patient transfer to ward
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Method of measurement
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Electrocardiographic monitoring, non-invasive automatic barometer and oximeter pulse
Intervention groups
1
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Description
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Intervention group: Patients with ASA Class I, II
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Category
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Treatment - Devices
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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Kashan 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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Yes - There is 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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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Part of the data, such as pipe and chip information, can be shared.
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When the data will become available and for how long
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Start access period 1 month after publishing results
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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With the permission of the person responsible for the unused use plan.
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From where data/document is obtainable
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person responsible
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What processes are involved for a request to access data/document
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Email to responsible
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Comments
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