Protocol summary

Study aim
Investigating the effect of anesthesia without drugs on the condition of patients undergoing thoracoscopic chest surgery
Design
In this study, which will be conducted in phase 3 of the clinical trial, a number of 60 patients, according to the entry and non-entry criteria and after obtaining the consent certificate for participation in the study, were randomly (using permuted blocks) and one-sidedly blinded to Two intervention groups (number = 30) and control (number = 30) will be divided. Patients of both groups will be operated by the same surgical and anesthesia team.
Settings and conduct
This study will be conducted in phase 3 of the clinical trial randomly (using permuted blocks) and one-sidedly blinded on patients who are candidates for thoracostomy surgery referring to Masih Daneshvari Hospital.
Participants/Inclusion and exclusion criteria
Entry requirements Candidate for thoracoscopic surgery - 18 < age < 70 years Non-entry conditions: Sensitivity to ketamine, sensitivity to dexmedetomidine, symptoms of increased ICP or history of cardiovascular diseases, active gastric ulcer, active GIB bleeding, liver and kidney failure, history of drug and alcohol addiction, corticosteroid use in the two weeks leading to surgery
Intervention groups
In the control group: induction of anesthesia with the continue method (prescribing fentanyl and midazolam, atracurium and propofol to induce anesthesia and to maintain isoflurane gas) will be used. In the intervention group: induction of anesthesia using midazolam, atracurium, propofol and ketamine and maintenance using isoflurane gas and dexmedetomidine will be done.
Main outcome variables
Type of medicine used during surgery; Type of medicine used after surgery; duration of surgery; Duration of anesthesia; Recovery time; Duration of hospitalization in ICU; Complications after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240407061439N1
Registration date: 2024-07-05, 1403/04/15
Registration timing: prospective

Last update: 2024-07-05, 1403/04/15
Update count: 0
Registration date
2024-07-05, 1403/04/15
Registrant information
Name
Moein Daneshmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 3888
Email address
moein.daneshmand@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of opioid free anesthesia on the condition of patients undergoing thoracoscopic surgery
Public title
opioid free anesthesia in thoracoscopic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 < age < 70 candidate for thoracoscopic surgery
Exclusion criteria:
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is Random Permuted Blocks. For this purpose, two treatment groups A and B are defined as groups AB and BA. Then random table numbers are defined in the range of 0 to 9. Therefore, we consider the numbers 0 to 4 for the AB block and the numbers 5 to 9 for the BA group. Then random numbers are selected from the table. The number 0 is related to block AB, and therefore two people enter this block. So that the first person receives treatment A and the second person receives treatment B. In the same way, treatment groups are determined for other people. Although in this method, the number of observations of both groups will be the same, but due to the small size of the blocks, the possibility of predicting the treatment group by the person performing it is high. To solve this problem: the randomization list is done before the start of the study by a blinded person who is outside the treatment team. We will also increase the size of the blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be blinded to the type of procedure performed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Masih Daneshvari Educational, Research and Treatment Center for Tuberculosis and Pulmonary Diseases,
Street address
Daar-Abad, Niavaran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2024-03-05, 1402/12/15
Ethics committee reference number
IR.SBMU.NRITLD.REC.1402.234

Health conditions studied

1

Description of health condition studied
Thoracostomy
ICD-10 code
Z93.80
ICD-10 code description
Thoracostoma status

Primary outcomes

1

Description
Duration of anesthesia
Timepoint
After the intervention at the end of the surgical procedure
Method of measurement
Use of surgical information

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Anesthesia will be induced using midazolam, atracurium, propofol, and ketamine, and maintenance will be done using isoflurane and dexmedetomidine.
Category
Treatment - Other

2

Description
Control group: Induction of anesthesia with the continue method (prescribing fentanyl and midazolam, atracurium and propofol to induce anesthesia and to maintain isoflurane gas) will be used.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Deneshvari Hospital
Full name of responsible person
Moein Daneshmand
Street address
Daar-Abad, Niavaran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3766
Email
moein.daneshmand@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Yemen St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1920
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Moein Daneshmand
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Daar-Abad, Niavaran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3766
Email
Moein.daneshmand@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Moein Daneshmand
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Daar-Abad, Niavaran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3766
Email
moein.daneshmand@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Bashir Mirtajani
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular genetics
Street address
Daar-Abad, Niavaran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3766
Email
bashirmirtajani67@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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