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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

CELALEDDİN SOYALP, Asist. Prof. contact

5068456504

c.soyalp@hotmail.com

YUZKAT NUREDDIN, Asist. Prof contact

+905052294728

nyuzkat@gmail.com

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.

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 groups in NCT03824470
Study groupRoleWhat 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.

  1. 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.

  1. First posted31 Jan 2019
  2. Study start5 Feb 2019 (estimated)
  3. Primary completion15 Mar 2019 (estimated)
  4. Study completion30 Mar 2019 (estimated)

Resources

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)
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

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; AzTrials last refreshed its copy on 7 Nov 2026.

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