Postoperative Residual CurarizationNCT05051371
Postoperative Residual Curarization in Elderly Patients in Post-anesthesia Care Unit
An observational study of Postoperative Residual Curarization and Geriatrics, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to determine the knowledge levels and approaches of anesthesiologists working in our clinic about postoperative residual curarization(PORC) in elderly patients with a questionnaire. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Postoperative Residual Curarization, Geriatrics
- What is being tested?
- Train of four monitoring
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2021to Dec 2021
- 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Electively operated elderly patients >65 years old under general anesthesia
Who may be able to join
- age >65
- general anesthesia using non-depolarizing neuromuscular blocker
Who cannot join
- Patients with an ASA score greater than 3
- Those with contraindications to anesthetic drugs
- Those with neuromuscular, neurological and psychiatric diseases
- Patients in whom TOF monitoring is not possible in the ulnar nerve region
- Patients with advanced renal failure
- Patients with advanced hepatic insufficiency
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- Those with decompensated heart failure
- Patients with BMI<18 and BMI>30
- Patients with uncontrolled hypertension, uncontrolled diabetes, pheochromocytoma, thyroid dysfunction
- Those who are incapable of reading and signing the consent form
- Patients who do not want to sign the consent form
- Patients deemed unsuitable by the investigator
- Those with chronic opioid use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara, 06800
Aysun Postaci, As.Prof.Dr.
About this study
Official title: Incidence of Postoperative Residual Curarization in Elderly Patients in the Post-anesthesia Care Unit, and Attitude and Awareness Questionnaire of Anesthesiologists
In this study, we aimed to determine the knowledge levels and approaches of anesthesiologists working in our clinic about postoperative residual curarization(PORC) in elderly patients with a questionnaire. In addition, we aimed to determine the incidence of PORC and factors associated with PORC in the recovery unit in elderly patients over 65 years of age who underwent surgery under general anesthesia using muscle relaxants with a prospective observational study.
Read the detailed description
Postoperative residual curarization (PORC) after general anesthesia is an important complication that can cause adverse patient outcomes, including symptoms of airway obstruction, hypoxia, respiratory distress, muscle weakness, and dyspnea in the early and late stages.
Anticholinesterase agents are commonly used to reverse neuromuscular blockade. Even with the use of anticholinesterase, severe PORC can be seen. The use of anticholinesterases in elderly patients is controversial due to the high side-effect profile.
Sugammadex, which has been widely used with its approval by the United States Food and Drug Administration in 2015, is a reverse agent that acts through a different mechanism than traditional anticholinesterase agents (it is a cyclodextrin molecule that encapsulates steroid neuromuscular blockers). Compared to neostigmine, sugammadex reverses neuromuscular blockade faster and more reliably.
In this study, we aimed to determine the knowledge levels and approaches of anesthesiologists working in our clinic about postoperative residual curarization(PORC) in elderly patients with a questionnaire. In addition, we aimed to determine the incidence of PORC and factors associated with PORC in the recovery unit in elderly patients over 65 years of age who underwent surgery under general anesthesia using muscle relaxants with a prospective observational study.
The first phase of the study is a prospective observational study. Elderly patients (>65) who are scheduled to undergo elective surgery under general anesthesia and require intubation using muscle relaxants will be screened for PORC using Train of four monitor in the recovery unit.
In the second phase of the study, an online questionnaire with 15 questions will determine the knowledge and attitudes of anesthesiologists working in our clinic on the use of muscle relaxants and reversing agents in elderly patients, the use of neuromuscular monitoring and PORC.
- Conditions
- Postoperative Residual Curarization, Geriatrics
- Being tested
- Train of four monitoring
- Keywords
- Postoperative residual curarization, Geriatrics, Train of four
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Train of four monitoringDevice
Train of four monitoring in postoperative care unit
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative residual curarization
The incidence of elderly patients that Train of Four(TOF) rate <0.9 in the postoperative care unit
Measured: through study completion( anticipated 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start15 Aug 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Residual CurarizationStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysun postaci, Ankara City Hospital Bilkent
- Investigators
- Aysun Postaci, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051371
- Sponsor's protocol ID
- E1-21-1912
- Status last verified
- Sep 2021
- First submitted
- 2 Aug 2021
- Last updated
- 21 Sep 2021
- 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 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Residual Curarization in Elderly Patients in the Post-anesthesia Care Unit, and Attitude and Awareness Questionnaire of Anesthesiologists
- ClinicalTrials.gov ID
- NCT05051371
- Acronym / sponsor ID
- E1-21-1912
- Conditions
- Postoperative Residual Curarization, Geriatrics
- Keywords
- Postoperative residual curarization, Geriatrics, Train of four
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Sep 2021 (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.
In this study, we aimed to determine the knowledge levels and approaches of anesthesiologists working in our clinic about postoperative residual curarization(PORC) in elderly patients with a questionnaire. In addition, we aimed to determine the incidence of PORC and factors associated with PORC in the recovery unit in elderly patients over 65 years of age who underwent surgery under general anesthesia using muscle relaxants with a prospective observational study.
Detailed description
Postoperative residual curarization (PORC) after general anesthesia is an important complication that can cause adverse patient outcomes, including symptoms of airway obstruction, hypoxia, respiratory distress, muscle weakness, and dyspnea in the early and late stages.
Anticholinesterase agents are commonly used to reverse neuromuscular blockade. Even with the use of anticholinesterase, severe PORC can be seen. The use of anticholinesterases in elderly patients is controversial due to the high side-effect profile.
Sugammadex, which has been widely used with its approval by the United States Food and Drug Administration in 2015, is a reverse agent that acts through a different mechanism than traditional anticholinesterase agents (it is a cyclodextrin molecule that encapsulates steroid neuromuscular blockers). Compared to neostigmine, sugammadex reverses neuromuscular blockade faster and more reliably.
In this study, we aimed to determine the knowledge levels and approaches of anesthesiologists working in our clinic about postoperative residual curarization(PORC) in elderly patients with a questionnaire. In addition, we aimed to determine the incidence of PORC and factors associated with PORC in the recovery unit in elderly patients over 65 years of age who underwent surgery under general anesthesia using muscle relaxants with a prospective observational study.
The first phase of the study is a prospective observational study. Elderly patients (>65) who are scheduled to undergo elective surgery under general anesthesia and require intubation using muscle relaxants will be screened for PORC using Train of four monitor in the recovery unit.
In the second phase of the study, an online questionnaire with 15 questions will determine the knowledge and attitudes of anesthesiologists working in our clinic on the use of muscle relaxants and reversing agents in elderly patients, the use of neuromuscular monitoring and PORC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Electively operated elderly patients >65 years old under general anesthesia
Key inclusion criteria (2 listed)
- age >65
- general anesthesia using non-depolarizing neuromuscular blocker
Key exclusion criteria (13 listed)
- Patients with an ASA score greater than 3
- Those with contraindications to anesthetic drugs
- Those with neuromuscular, neurological and psychiatric diseases
- Patients in whom TOF monitoring is not possible in the ulnar nerve region
- Patients with advanced renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Train of four monitoringTrain of four monitoring in postoperative care unit | Device | – |
Primary outcome
The incidence of postoperative residual curarization
Time frame: through study completion( anticipated 5 months)
The incidence of elderly patients that Train of Four(TOF) rate <0.9 in the postoperative care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- 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.
Aysun Postaci principal investigator
Ankara City Hospital Bilkent
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 Postoperative Residual Curarization and Geriatrics, run by Ankara City Hospital Bilkent 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 13 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 21 Sep 2021. 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 Aysun Postaci (+90 5323520383, aysunposta@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative residual curarization (time frame: through study completion( anticipated 5 months)). 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 21 Sep 2021.