Comparative study of Rocuronium deep muscular blockage in Isofluorane and Total Intravenous Anesthesia (TIVA) on peritoneal compliance and surgical conditions during laparoscopic cholecystectomy
Comparative study of Rocuronium deep muscular blockage in two anesthesia groups on peritoneal compliance and surgical conditions in laparoscopic cholecystectomy
Design
80 patients who are candidates for laparoscopic cholecystectomy are classified in two groups.
The first group receives inhalation anesthesia and the maintance with Isofluoran, Remifentanil, and mixture of air and oxygen.
The second group receives total intravenous anesthesia with Propofol and Remifentanil and a mixture of oxygen and air.
The muscular relaxant used in both groups is Rocronium. The extent of relaxation will be monitored.
Deep muscular blockage is called TOF = 0 and PTC = 0-4. Peritoneal pressure and the quality of operating conditions will be studied using conventional methods and compared in two groups.
Settings and conduct
Muscular blockage is monitored to maintain TOF = 1-3 and PTC = 4-8, and the Rocuronium infusion is started at a rate of 20 mg per hour and titrated for relaxation. To achieve TOF = 0 and PTC = 0-4, the surgeon's satisfaction and the quality of the operating conditions are recorded.
This study will be conducted in Imam Reza Hospital of Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Patients with cholecystitis undergoing laparoscopic cholecystectomy
Age of 18-65 years
BMI < 35
Conscious consent
Lack of allergic reactions to all medications used
Lack of hypertension, liver, kidney, lung and neuromuscular diseases, no history of aspiration, active infection, dwarf
Intervention groups
Group one: Deep muscular blockage of Rocoronium in patients with inhalation anesthesia
Group two: Deep muscular blockage of Rocoronium in patients with total intravenous anesthesia
Main outcome variables
Intra-abdominal pressure and quality of surgical conditions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220519054914N1
Registration date:2022-07-01, 1401/04/10
Registration timing:prospective
Last update:2022-07-01, 1401/04/10
Update count:0
Registration date
2022-07-01, 1401/04/10
Registrant information
Name
Hamzeh Hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
hamzeh1338@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of Rocuronium deep muscular blockage in Isofluorane and Total Intravenous Anesthesia (TIVA) on peritoneal compliance and surgical conditions during laparoscopic cholecystectomy
Public title
Comparative study of Rocuronium deep muscular blockage in laparoscopic cholecystectomy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing laparoscopic cholecystectomy
Conscious consent for study
No allergic reaction to all drugs used
BMI (Body Mass Index) <35
Lack of hypertension, respiratory disease, history of aspiration, liver and kidney diseases, neuromuscular diseases, dwarf and patients with active infection
Exclusion criteria:
Dissatisfaction
BMI>35
Patients whose operation is finally opened
Allergic reaction to all drugs used
Hypertension, respiratory disease, history of aspiration, liver and kidney diseases, neuromuscular diseases, dwarf and patients with active infection
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial diagnosis, patients are divided into groups of one or two based on a sealed envelope to be nominated for surgery. Group one will receive the inhalation method and the second group will receive the complete intravenous method. It should be noted that it is typed in approximately 40 envelopes of group one and in the next 40 envelopes of the second group, and each patient chooses an envelope without knowing the contents of the envelope.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient, the surgeon, and the person who is collecting the data are blinded to the type of anesthesia and the details.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Deep muscular blockage with Rocoronium and abdominal compliance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of deep muscular blockage on intra-abdominal pressure in laparoscopic cholecystectomy after inhaled anesthesia in laparascopic cholecystectomy
Timepoint
Muscular blockage is monitored to maintain TOF = 1-3, PTC = 4-8. To maintain the blockage, Rocuronium infusion is started at a rate of 20 mg per hour and titrated for the desired relaxation. Intra-abdominal pressure is measured at this rate of relaxation. In groups with deep relaxation, the rate of Rocronium infusion will be increased and titrated to achieve TOF = 0 and PTC = 0-4. Changes in abdominal pressure are measured in both anesthesic methods.
Method of measurement
Intra-abdominal pressure will be measured with laparoscope and the abdominal compliance by measuring the length of the xiphoid to the pubis
2
Description
The effect of deep muscular blockage with Recuronium on intra-abdominal pressure in laparoscopic cholecystectomy with total intravenous anesthesia
Timepoint
Before and after deep muscular blockage
Method of measurement
The TOF and POC values will be measured before and after deep muscular blockage
Secondary outcomes
1
Description
The effect of deep muscular blockage with Recuronium on the quality of operating conditions in laparoscopic cholecystectomy anesthesized with isoflurane
Timepoint
Before and after deep muscular blockage
Method of measurement
1: Extremely poor conditions: the surgeon is unable to work because of coughing or because of the inability to obtain a visible laparoscopic field because of inadequate muscle relaxation. Additional neuromuscular blocking agents must be given.2: Poor conditions: there is a visible laparoscopic field, but the surgeon is severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional neuromuscular blocking agents must be given.3: Acceptable conditions: there is a wide visible laparoscopic field, but muscle contractions, movements, or both occur regularly, causing some interference with the surgeon’s work. There is a need for additional neuromuscular blocking agents to prevent deterioration.4: Good conditions: there is a wide laparoscopic working field with sporadic muscle contractions, movements, or both. There is no immediate need for additional neuromuscular blocking agents unless there is a fear of deterioration.5: Optimal conditions: there is a wide visible laparoscopic working field without any movement or contractions.
2
Description
The effect of deep muscular blockage with Rocronium on the quality of operating conditions in laparoscopic cholecystectomy with total intra venous anesthesia
Timepoint
Before and after deep muscular blockage
Method of measurement
1: Extremely poor conditions: the surgeon is unable to work because of coughing or because of the inability to obtain a visible laparoscopic field because of inadequate muscle relaxation. Additional neuromuscular blocking agents must be given.2: Poor conditions: there is a visible laparoscopic field, but the surgeon is severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional neuromuscular blocking agents must be given.3: Acceptable conditions: there is a wide visible laparoscopic field, but muscle contractions, movements, or both occur regularly, causing some interference with the surgeon’s work. There is a need for additional neuromuscular blocking agents to prevent deterioration.4: Good conditions: there is a wide laparoscopic working field with sporadic muscle contractions, movements, or both. There is no immediate need for additional neuromuscular blocking agents unless there is a fear of deterioration.5: Optimal conditions: there is a wide visible laparoscopic working field without any movement or contractions.
Intervention groups
1
Description
The first intervention group: Deep muscular blockage (TOF=0 or PTC=0-4) with Rocuronium accompanied by inhalation anesthesia
Category
Treatment - Surgery
2
Description
The second intervention group: Deep muscular blockage (TOF=0 or PTC=0-4) with Rocuronium accompanied by total intravenous anesthesia
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hamzeh Hosseinzadeh
Street address
Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167754836
Phone
+98 41 3334 7054
Email
hamzeh1338@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Golgasht Street, Tabriz University of Medical Sciences, Vice Chancellor for Research and Technology
City
Tabriz
Province
East Azarbaijan
Postal code
04133344280
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hamzeh Hosseinzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5167754836
Phone
+98 41 3334 7054
Email
hamzeh1338@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamzeh Hosseinzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5167754836
Phone
+98 41 3334 7054
Email
hamzeh1338@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamzeh Hosseinzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5167754836
Phone
+98 41 3334 7054
Email
hamzeh1338@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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