Protocol summary
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Study aim
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Investigating the effect of dexmedetomidine in preventing delirium after esophagectomy surgery
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Design
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In this double-blind clinical trial study (participants and results analyzer), patients will undergo surgery after random allocation in the two mentioned groups. For one group, dexmedetomidine drug will be injected intravenously, and for the other group, normal saline will be injected intravenously, agitation after surgery will be compared between the two groups.
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Settings and conduct
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This study was conducted as a randomized clinical trial (blocks of four), double blind (participants and results analyzer), with parallel groups, without a control group and with the participation of 60 patients with esophagectomy surgery referred to Imam Reza Hospital (Tabriz).
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Participants/Inclusion and exclusion criteria
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The criteria for entering the study include: candidate for esophagectomy surgery, duration of surgery between three to five hours and the same anesthesia method for all patients, and exclusion criteria also include: ASA class higher than III, body mass index greater than 30, heart rate less than 50 times per minute and sensitivity to dexmedetomidine.
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Intervention groups
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In this study, patients who will refer to the operating room due to esophagectomy surgery will be subjected to intervention. Patients will be randomly divided into two groups. For one group, dexmedetomidine drug will be injected intravenously, and for the other group, normal saline will be injected intravenously, agitation after surgery will be compared between the two groups.
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Main outcome variables
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Agitation
General information
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Reason for update
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Hello and greetings,
Respectfully, the number of samples was mistakenly entered as 80 instead of 60 during the registration in the trial system, which has now been corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190325043107N42
Registration date:
2024-01-07, 1402/10/17
Registration timing:
prospective
Last update:
2024-10-27, 1403/08/06
Update count:
1
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Registration date
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2024-01-07, 1402/10/17
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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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2024-01-19, 1402/10/29
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Expected recruitment end date
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2025-01-18, 1403/10/29
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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 dexmedetomidine in preventing delirium after esophagectomy surgery
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Public title
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Investigating the effect of dexmedetomidine in preventing delirium after esophagectomy surgery
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Candidate for esophagectomy surgery
The duration of the surgery is between three and five hours
Same anesthesia method for all patients
Exclusion criteria:
Body mass index greater than 30
ASA class above III
Heart rate less than 50 beats per minute
Allergy to dexmedetomidine
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Age
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From 18 years old to 65 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
- 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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In this study, with a sample size of 60, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 15 blocks for 60 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they will divid into two intervention groups (group A) and control group (group B).
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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 thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. Since the participants will be unaware of the type of drug used, in this study they will not know what type of drug will be used in other patients.
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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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2023-12-18, 1402/09/27
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Ethics committee reference number
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IR.TBZMED.REC.1401.859
Health conditions studied
1
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Description of health condition studied
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Agitation
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ICD-10 code
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R45.1
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ICD-10 code description
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Restlessness and agitation
Primary outcomes
1
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Description
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Agitation
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Timepoint
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Three times in three days and once every day
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Method of measurement
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Examination by a neurologist
Intervention groups
1
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Description
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Intervention group: Patients will be randomly assigned to this group. Immediately after the induction of anesthesia, the patients will receive the intervention. Dexmedetomidine will be injected at a rate of 0.5 micrograms/kg per hour. The drug infusion will continue until the end of the surgery (the end of the surgical dressing). Finally, the degree of delirium will be measured once every 24 hours for all patients until the third day after discharge from the operating room.
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Category
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Prevention
2
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Description
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Control group: Patients will be randomly assigned to this group. Immediately after the induction of anesthesia, the patients will receive the intervention. Normal saline injection will be done at a rate of 0.5 ml/kg per hour. The drug infusion will continue until the end of the surgery (the end of the surgical dressing). Finally, the degree of delirium will be measured once every 24 hours for all patients until the third day after discharge from the operating room.
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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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Tabriz 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