Obstructive Sleep Apnea SyndromeNCT03824470
The Effect of Intubation Without Muscle Relaxation on Post Operative Recovery Conditions: Double Blind Randomized Controlled Study
An observational study of Obstructive Sleep Apnea Syndrome, run by Yuzuncu Yil University.
Trial summary
The primary aim of this study is to research the effect of intubation without muscle relaxant on post-operative recovery conditions in patients with OSAS (obstructive sleep apnea syndrome). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2019to 30 Mar 2019
- 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
- Adult, Older adult
Study population: the patiens whose Stop Bang questionnaire bigger tan 3 and planned for elective surgery
Who may be able to join
- Aged18- 65 years With a stop bang score of 3 ASA I-II Mallampati I and II scores
Who cannot join
- Patients who were intubated in the intensive care unit during postoperative period, those using CPAP device at home or those who received OSAS therapy, who had undergone head and neck surgery or who had head surgery, central nervous system damage and cardiovascular or pulmonary stability, neuromuscular disease patients, those with known allergies to the anesthetic agents used, those whose written and verbal consent cannot be obtained, smokers, pregnants and patients with ASA III and IV will not be included in our study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Non-Muscle Intubation on Post Operative Recovery Conditions in Patients With Obstructive Sleep Apnea Syndrome: Double Blind Randomized Controlled Study
The primary aim of this study is to research the effect of intubation without muscle relaxant on post-operative recovery conditions in patients with OSAS (obstructive sleep apnea syndrome). Our secondary aim is to research the hemodynamic parameters in intraoperative period and complications such as sore throat and laryngospasm voice limitation in the postoperative period.
Read the detailed description
Study Protocol, Methods and Procedures to be Applied:
This study will be carried out as double blinded randomized controlled after the approval of the ethics committee of our hospital. By carrying out the Stop Bang questionnaire which is a practical and highly sensitive test, 60 patients ranging from 18 to 65 years with a stop bang score of 3 and ASA I-II and mallampati I and II scores will be included to the study. The patients included in the study will be divided into two groups of 30 people randomly with a closed envelope method. Patients who were intubated in the intensive care unit during postoperative period, those using CPAP device at home or those who received OSAS therapy, who had undergone head and neck surgery or who had head surgery, central nervous system damage and cardiovascular or pulmonary stability, neuromuscular disease patients, those with known allergies to the anesthetic agents used, those whose written and verbal consent cannot be obtained, smokers, pregnants and patients with ASA III and IV will not be included in our study. All patients will be seen a day in advance and after performing stop bang test, those with test score of 3 and above will be included in the study and their physical examinations and laboratory findings will be evaluated. The demographic data of the patients will be recorded. The physician performing the anesthesia and the evaluating physician will be different people. The evaluating physician will not know which anesthetic agent is used to the patients. The group to be performed Esmeron will be named Group E and the group to be given Remifentanil will be named Group R. All patients included in the study will be taken to the operation room and the hemodynamic parameters (heart rate, mean blood pressure values, SpO2) will be recorded by naninvasive monitoring. The data obtained will be considered as basal. All patients will be given 2 mg / kg demisolam for the purpose of sedation. General anesthesia will be done by connecting the Tof device to the patients. Anesthesia induction will be done to anesthesia induction Group R with 1 mg / kg lidocaine, 4 mcg / kg remifentanil and 2 mg / kg propofol intravenously. In group E, after the administration of 1 mg / kg lidocaine, 2 mg / kg propofol, 1 mcg / kg remifentanil and 0.6 mg / kg rocuronium, patients in both groups will be intubated and general anesthesia will be performed when the Tof value is 0. During intubation; intubation difficulty will be evaluated and recorded by intubation scoring system. Anesthesia maintenance in both groups will be provided with 8% desflurane, 40% O2, 60% dry air and iv. 0.025 mcg / kg / min remifentanil fusion. During the study, the recorded basal hemodynamic parameters of the patients will be recorded in the first 20 minutes of the operation with a 5-minute interval and 10-minute interval after the 20th minute. In case of a change of 20% in any one according to basal, it will be intervened immediately. In order to provide the depth of anesthesia before the operation, patients will be monitored with TOF device and the depth of anesthesia will be provided. Shortly after the end of the surgery, the gases will be cut off and the Tof value of 70% and above will be recorded. When Tof is 70%, Group R will be given 10 cc physiological saline intravenously. In order to antagonize the muscle relaxant effect in Group E, 2 / mg / kg sguamadex will be administered intravenously by diluting with 10 cc physiological saline. Patients will be extubated when the tof value of both groups is 90%. The durations from 70% to 90% of the Tof value, spontaneous eye opening duration after the patient is extubated, duration of extubation, response duration to commands, duration until modified aldrete score is 10, surgeon satisfaction (good, bad, moderate) and duration of surgery will be recorded. The operation will be terminated by recording whether there is a need for ventilation with sore throat, laryngospasm volume restriction, desaturation and mask.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- stop bang, Intubation Without Muscle Relaxation, Post Operative Recovery, TOF
- Medical subject headings
- Sleep Apnea, Obstructive
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 |
|---|---|---|
| Group E(rocuronium) | E, after the administration of 1 mg / kg lidocaine, 2 mg / kg propofol, 1 mcg / kg remifentanil and 0.6 mg / kg rocuronium intravenously, patients will be intubated and general anesthesia will be performed when the Tof value is 0. | |
| Group R (remifentanil) | 1 mg / kg lidocaine, 4 mcg / kg remifentanil and 2 mg / kg propofol intravenously.patients will be intubated and general anesthesia will be performed when the Tof value is 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Recovery
The durations from 70% to 90% of the Tof value, spontaneous eye opening duration after the patient is extubated, duration of extubation, response duration to commands, duration until modified aldrete score is 10
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start5 Feb 2019 (estimated)
- Primary completion15 Mar 2019 (estimated)
- Study completion30 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celaleddin Soyalp, Yuzuncu Yil University
- Investigators
- CELALEDDİN Y SOYALP, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824470
- Sponsor's protocol ID
- stop bang
- Status last verified
- Jan 2019
- First submitted
- 29 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-Muscle Intubation on Post Operative Recovery Conditions in Patients With Obstructive Sleep Apnea Syndrome: Double Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03824470
- Acronym / sponsor ID
- stop bang
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- stop bang, Intubation Without Muscle Relaxation, Post Operative Recovery, TOF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 5 Feb 2019 (estimated)
- Primary completion
- 15 Mar 2019 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 31 Jan 2019 (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.
The primary aim of this study is to research the effect of intubation without muscle relaxant on post-operative recovery conditions in patients with OSAS (obstructive sleep apnea syndrome). Our secondary aim is to research the hemodynamic parameters in intraoperative period and complications such as sore throat and laryngospasm voice limitation in the postoperative period.
Detailed description
Study Protocol, Methods and Procedures to be Applied:
This study will be carried out as double blinded randomized controlled after the approval of the ethics committee of our hospital. By carrying out the Stop Bang questionnaire which is a practical and highly sensitive test, 60 patients ranging from 18 to 65 years with a stop bang score of 3 and ASA I-II and mallampati I and II scores will be included to the study. The patients included in the study will be divided into two groups of 30 people randomly with a closed envelope method. Patients who were intubated in the intensive care unit during postoperative period, those using CPAP device at home or those who received OSAS therapy, who had undergone head and neck surgery or who had head surgery, central nervous system damage and cardiovascular or pulmonary stability, neuromuscular disease patients, those with known allergies to the anesthetic agents used, those whose written and verbal consent cannot be obtained, smokers, pregnants and patients with ASA III and IV will not be included in our study. All patients will be seen a day in advance and after performing stop bang test, those with test score of 3 and above will be included in the study and their physical examinations and laboratory findings will be evaluated. The demographic data of the patients will be recorded. The physician performing the anesthesia and the evaluating physician will be different people. The evaluating physician will not know which anesthetic agent is used to the patients. The group to be performed Esmeron will be named Group E and the group to be given Remifentanil will be named Group R. All patients included in the study will be taken to the operation room and the hemodynamic parameters (heart rate, mean blood pressure values, SpO2) will be recorded by naninvasive monitoring. The data obtained will be considered as basal. All patients will be given 2 mg / kg demisolam for the purpose of sedation. General anesthesia will be done by connecting the Tof device to the patients. Anesthesia induction will be done to anesthesia induction Group R with 1 mg / kg lidocaine, 4 mcg / kg remifentanil and 2 mg / kg propofol intravenously. In group E, after the administration of 1 mg / kg lidocaine, 2 mg / kg propofol, 1 mcg / kg remifentanil and 0.6 mg / kg rocuronium, patients in both groups will be intubated and general anesthesia will be performed when the Tof value is 0. During intubation; intubation difficulty will be evaluated and recorded by intubation scoring system. Anesthesia maintenance in both groups will be provided with 8% desflurane, 40% O2, 60% dry air and iv. 0.025 mcg / kg / min remifentanil fusion. During the study, the recorded basal hemodynamic parameters of the patients will be recorded in the first 20 minutes of the operation with a 5-minute interval and 10-minute interval after the 20th minute. In case of a change of 20% in any one according to basal, it will be intervened immediately. In order to provide the depth of anesthesia before the operation, patients will be monitored with TOF device and the depth of anesthesia will be provided. Shortly after the end of the surgery, the gases will be cut off and the Tof value of 70% and above will be recorded. When Tof is 70%, Group R will be given 10 cc physiological saline intravenously. In order to antagonize the muscle relaxant effect in Group E, 2 / mg / kg sguamadex will be administered intravenously by diluting with 10 cc physiological saline. Patients will be extubated when the tof value of both groups is 90%. The durations from 70% to 90% of the Tof value, spontaneous eye opening duration after the patient is extubated, duration of extubation, response duration to commands, duration until modified aldrete score is 10, surgeon satisfaction (good, bad, moderate) and duration of surgery will be recorded. The operation will be terminated by recording whether there is a need for ventilation with sore throat, laryngospasm volume restriction, desaturation and mask.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E(rocuronium) | – | –E, after the administration of 1 mg / kg lidocaine, 2 mg / kg propofol, 1 mcg / kg remifentanil and 0.6 mg / kg rocuronium intravenously, patients will be intubated and general anesthesia will be performed when the Tof value is 0. |
| Group R (remifentanil) | – | –1 mg / kg lidocaine, 4 mcg / kg remifentanil and 2 mg / kg propofol intravenously.patients will be intubated and general anesthesia will be performed when the Tof value is 0 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- the patiens whose Stop Bang questionnaire bigger tan 3 and planned for elective surgery
Key inclusion criteria (1 listed)
- Aged18- 65 years With a stop bang score of 3 ASA I-II Mallampati I and II scores
Key exclusion criteria (1 listed)
- Patients who were intubated in the intensive care unit during postoperative period, those using CPAP device at home or those who received OSAS therapy, who had undergone head and neck surgery or who had head surgery, central nervous system damage and cardiovascular or pulmonary stability, neuromuscular disease patients, those with known allergies to the anesthetic agents used, those whose written and verbal consent cannot be obtained, smokers, pregnants and patients with ASA III and IV will not be included in our study.
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
Post Operative Recovery
Time frame: 1 hour
The durations from 70% to 90% of the Tof value, spontaneous eye opening duration after the patient is extubated, duration of extubation, response duration to commands, duration until modified aldrete score is 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
CELALEDDİN Y SOYALP study chair
Yuzuncu Yil University
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea Syndrome, run by Yuzuncu Yil University.
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 1 inclusion and 1 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 CELALEDDİN SOYALP, Asist. Prof. (5068456504, c.soyalp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Recovery (time frame: 1 hour). 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 31 Jan 2019.