Neuromuscular BlockadeNCT06045559
Effects of Anesthetics on High-Dose Rocuronium
An observational study of Neuromuscular Blockade and Anesthetic Agents, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effects of three different anesthetics on high dose rocuronium in laparoscopic cholecystectomy cases. Patients were randomly assigned to one of the propofol, desflurane, or sevoflurane groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Blockade, Anesthetic Agents
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 2 Sep 2024
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 18 and 65 who applied to our hospital for laparoscopic cholecystectomy surgery from October 2023 to June 2024.
Who may be able to join
- American Society of Anesthesiology (ASA) Ⅰ-Ⅲ patients
- between the ages of 18-65
Who cannot join
- Being under 18 of age or over 65
- disapproval of the informed consent
- rocuronium allergy
- sugammadex allergy
- pregnancy
- lactation
Show all 11Show fewer
- hepatic or renal dysfunction
- obesity (BMI≥35kg/m2)
- Previous abdominal surgery
- long-term use of NSAIs
- neuromuscular disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hatay Mustafa Kemal University
Antakya, Hatay, 31100
Selim Turhanoglu, MD, +905325062988, adat63@gmail.com
About this study
Official title: Effects of Sevoflurane, Desflurane or Propofol Anesthesia on High-Dose Rocuronium in Laparoscopic Cholecystectomy Operations
This study evaluates the effects of three different anesthetics on high dose rocuronium in laparoscopic cholecystectomy cases. Patients were randomly assigned to one of the propofol, desflurane, or sevoflurane groups. Train of four (TOF) and bispectral index (BIS) monitoring were used during surgery in all groups.Patients were followed until TOF and post tetanic count (PTC) values reached 1 and the time was recorded.The effect of three anesthetic drugs used on the duration of the muscle relaxant drug was investigated.
Read the detailed description
In recent years, studies have been published showing that by applying deep neuromuscular block during laparoscopic cholecystectomy, intraabdominal pressure can be reduced without compromising the surgical conditions, thus complications such as postoperative nausea and vomiting (PONV) and pain can be reduced.
The results we obtained in our previous study showed that deep neuromuscular block achieved with a high dose of 1.2 mg/kg rocuronium allowed the operation to be performed with lower intra-abdominal pressure values, shortened the operation time, reduced PONV and pain in laparoscopic cholecystectomy cases. The most important factor affecting the depth of neuromuscular block is the dose of the neuromuscular agent. However, anesthetic agents can also affect the depth of neuromuscular blockade. The effects of muscle relaxants are enhanced when administered together with inhalation anesthetics.Propofol and sevoflurane are widely used in the maintenance of anesthesia. Unlike propofol, sevoflurane enhances the effects of some neuromuscular blocking drugs, including rocuronium.
Our primary aim in this study is to evaluate the effects of sevoflurane, desflurane, or propofol, which are commonly used in anesthesia maintenance, on the duration of neuromuscular block caused by 1.2 mg/kg rocuronium, which is the dose we routinely use in anesthesia induction, in laparoscopic cholecystectomy cases. Secondary aims are to investigate its effects on intraabdominal pressures and surgical conditions, and to determine whether it reduces postoperative pain and PONV, as well as extubation and recovery times.
- Conditions
- Neuromuscular Blockade, Anesthetic Agents
- Keywords
- inhalational anesthetics, Neuromuscular Blockade, rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| S(Sevoflurane) | Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Anesthesia will be maintained with sevoflurane, with a BIS value between 40-50 and a minimal alveolar concentration (MAC) value between 1-1.5. | |
| D(Desflurane) | Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Anesthesia will be maintained with desflurane, with a BIS value between 40-50 and a MAC value between 1-1.5. | |
| P(Propofol) | Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Propofol was administered intravenously at a rate of 6-12 mg/kg/min to maintain anesthesia, keeping the BIS value between 40-50. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of neuromuscular block with rocuronium.
TOF rates will be measured every 15 seconds and PTC values will be measured every 8 minutes. Additionally, the times of TOF 0 and PTC 0 responses and TOF1 and PTC 1 responses will be recorded.
Measured: 15 seconds for TOF rates, 8 minutes for PTC values
Secondary outcomes (6)
intra-abdominal pressure
Effect of deep neuromuscular block on intra-abdominal pressure
Measured: 5 minutes
surgical conditions
Effect of deep neuromuscular block on surgical conditions
Measured: It will be evaluated once at the end of the surgery based on the surgeon's satisfaction.
postoperative pain
Effect of deep neuromuscular block on postoperative pain
Measured: 2nd, 24th and 72nd hours after surgery
postoperative nausea and vomiting
The effect of deep neuromuscular blockade on postoperative nausea and vomiting will be evaluated.
Measured: postoperative 4th, 12th and 24th hours
Length of extubation process
Time from discontinuation of maintenance anesthesia to extubation.
Measured: 15sc
Lenght of recovery process
Time from extubation to modified Aldrete score of 9.
Measured: 1 mınute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 Oct 2023
- Primary completion28 Jun 2024 (estimated)
- Study completion2 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Turhanoglu, Mustafa Kemal University
- Investigators
- Selim Turhanoglu, MD, Principal investigator, Mustafa Kemal UniversitySerhat Hakkoymaz, MD, Study director, Mustafa Kemal UniversityMenekşe Okşar, MD, Study director, Mustafa Kemal UniversityMuhyittin Temiz, MD, Study director, Mustafa Kemal UniversityEmre Dirican, Study director, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045559
- Sponsor's protocol ID
- 2022/38
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sevoflurane, Desflurane or Propofol Anesthesia on High-Dose Rocuronium in Laparoscopic Cholecystectomy Operations
- ClinicalTrials.gov ID
- NCT06045559
- Acronym / sponsor ID
- 2022/38
- Conditions
- Neuromuscular Blockade, Anesthetic Agents
- Keywords
- inhalational anesthetics, Neuromuscular Blockade, rocuronium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 2 Sep 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of three different anesthetics on high dose rocuronium in laparoscopic cholecystectomy cases. Patients were randomly assigned to one of the propofol, desflurane, or sevoflurane groups. Train of four (TOF) and bispectral index (BIS) monitoring were used during surgery in all groups.Patients were followed until TOF and post tetanic count (PTC) values reached 1 and the time was recorded.The effect of three anesthetic drugs used on the duration of the muscle relaxant drug was investigated.
Detailed description
In recent years, studies have been published showing that by applying deep neuromuscular block during laparoscopic cholecystectomy, intraabdominal pressure can be reduced without compromising the surgical conditions, thus complications such as postoperative nausea and vomiting (PONV) and pain can be reduced.
The results we obtained in our previous study showed that deep neuromuscular block achieved with a high dose of 1.2 mg/kg rocuronium allowed the operation to be performed with lower intra-abdominal pressure values, shortened the operation time, reduced PONV and pain in laparoscopic cholecystectomy cases. The most important factor affecting the depth of neuromuscular block is the dose of the neuromuscular agent. However, anesthetic agents can also affect the depth of neuromuscular blockade. The effects of muscle relaxants are enhanced when administered together with inhalation anesthetics.Propofol and sevoflurane are widely used in the maintenance of anesthesia. Unlike propofol, sevoflurane enhances the effects of some neuromuscular blocking drugs, including rocuronium.
Our primary aim in this study is to evaluate the effects of sevoflurane, desflurane, or propofol, which are commonly used in anesthesia maintenance, on the duration of neuromuscular block caused by 1.2 mg/kg rocuronium, which is the dose we routinely use in anesthesia induction, in laparoscopic cholecystectomy cases. Secondary aims are to investigate its effects on intraabdominal pressures and surgical conditions, and to determine whether it reduces postoperative pain and PONV, as well as extubation and recovery times.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| S(Sevoflurane) | – | –Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Anesthesia will be maintained with sevoflurane, with a BIS value between 40-50 and a minimal alveolar concentration (MAC) value between 1-1.5. |
| D(Desflurane) | – | –Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Anesthesia will be maintained with desflurane, with a BIS value between 40-50 and a MAC value between 1-1.5. |
| P(Propofol) | – | –Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Propofol was administered intravenously at a rate of 6-12 mg/kg/min to maintain anesthesia, keeping the BIS value between 40-50. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18 and 65 who applied to our hospital for laparoscopic cholecystectomy surgery from October 2023 to June 2024.
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) Ⅰ-Ⅲ patients
- between the ages of 18-65
Key exclusion criteria (11 listed)
- Being under 18 of age or over 65
- disapproval of the informed consent
- rocuronium allergy
- sugammadex allergy
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of neuromuscular block with rocuronium.
Time frame: 15 seconds for TOF rates, 8 minutes for PTC values
TOF rates will be measured every 15 seconds and PTC values will be measured every 8 minutes. Additionally, the times of TOF 0 and PTC 0 responses and TOF1 and PTC 1 responses will be recorded.
6 secondary outcomes
intra-abdominal pressure
Time frame: 5 minutes
surgical conditions
Time frame: It will be evaluated once at the end of the surgery based on the surgeon's satisfaction.
postoperative pain
Time frame: 2nd, 24th and 72nd hours after surgery
postoperative nausea and vomiting
Time frame: postoperative 4th, 12th and 24th hours
Length of extubation process
Time frame: 15sc
Lenght of recovery process
Time frame: 1 mınute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim Turhanoglu, MD principal investigator
Mustafa Kemal University
Serhat Hakkoymaz, MD study director
Mustafa Kemal University
Menekşe Okşar, MD study director
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade and Anesthetic Agents, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selim Turhanoglu, MD (+905325062988, adat63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of neuromuscular block with rocuronium. (time frame: 15 seconds for TOF rates, 8 minutes for PTC values). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.