Postoperative CareNCT06815510
Prevalence of Post Anesthesia Care Unit Complications and Associated Factors
An observational study of Postoperative Care and Complications of Surgical Procedures or Medical Care, run by Ángel Becerra-Bolaños, MD PhD at 4 sites in 2 countries.
Trial summary
The post-anesthesia care unit (PACU) is a crucial component of the surgical process, providing patients with vital support and monitoring as they recover from anesthesia. Despite advancements in perioperative anesthesia, PACU complications are still common. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Care, Complications of Surgical Procedures or Medical Care, Inpatients
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 1,778 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 24 Feb 2025to 30 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the Post-Anesthesia Care Units (PACUs) following surgery under general, regional, or monitored anesthesia who have signed the informed consent preoperatively will be included in the study.
Who may be able to join
- All patients admitted to the Post-Anesthesia Care Units (PACUs) following surgery under general, regional, or monitored anesthesia
Who cannot join
- Patients who are taken directly to the ICU, ward, discharged, or transferred immediately after surgery.
- Patients who do not provide informed consent for enrollment in the study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Ethiopia3 sites
Haramaya University
Harar
Jimma University
Jimma
Mekelle University
Mek'ele
Spain1 site
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria
About this study
Official title: Multicentral Observational Prospective Study on Prevalence of Post Anesthesia Care Unit Complications and Associated Factors
The post-anesthesia care unit (PACU) is a crucial component of the surgical process, providing patients with vital support and monitoring as they recover from anesthesia. Despite advancements in perioperative anesthesia, PACU complications are still common. PACU organization and setup in low-income country like Ethiopia is poor. Previous research's done in some neighbor African countries presumed to have comparable to sociodemographic and economical profile shows varied degree of incidence and prevalence of PACU complication and associated factors. The main objective of this study is to determine the prevalence of PACU complications and its associated factors.
An institutional based prospective cohort study will be conducted in the PACUs of the three selected tertiary care hospitals in Ethiopia from Februery 15, 2025 to June 30, 2025. These data will be compared with those obtained in a tertiary hospital in Spain.
Read the detailed description
Studying the prevalence and associated factors of PACU complications will be of great academic importance, serving as a valuable reference and resource for further research. It will also help identify risk factors attributable to PACU complications, providing critical insights for hospital administrators and policymakers in making informed decisions about resource allocation and system design to minimize these complications. Understanding the prevalence and potential risk factors of PACU complications is essential for optimizing patient care and improving outcomes. Identified risk factors for postoperative complications in the PACU include female sex, longer duration of anesthesia, and the occurrence of intraoperative complications. This study aims to explore the prevalence of complications in the PACU and identify potential contributing factors, providing valuable insights for healthcare providers and policymakers seeking to improve PACU care. the potential significance and implications of the study findings, includes; Improving the understanding of PACU complications and the associated risk factors, informing the development of targeted prevention and management strategies, enhancing patient safety and quality of care in the perioperative setting and providing a basis for future research and evidence-based clinical guidelines. The study will involve surgical patients admitted to the Post-Anesthesia Care Units (PACUs) of four hospitals: Hiwot Fana Comprehensive Specialized Hospital, Ayder Comprehensive Specialized Hospital, Jimma University Medical Center (Ethiopia) and Hospital Universitario de Gran Canaria Doctor Negrín (Spain). The research will take place from February 15, 2025, to June 30, 2025. Multicenter, prospective, observational cohort study will be conducted reviewing patients admitted to the PACU. Analyzing complications in all patients admitted to the PACUs at the four selected hospitals following surgery under general, regional, or monitored anesthesia will be included in the study.
- Conditions
- Postoperative Care, Complications of Surgical Procedures or Medical Care, Inpatients, Ethiopia, Multicenter Prospective Study
- Being tested
- Questionnaire and Physical Exam
- Keywords
- postoperative complications, postanesthesia care unit
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamDiagnostic test
Also called Postoperative complications in the PACU
Patients will be followed up to find out any of these complications: pulmonary, hemodynamic complications, temperature disturbances, or pain
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to the postanesthesia care unit | Adult patients admitted to the postanesthesia care unit following surgery under general, regional, or monitored anesthesia Receives: Diagnostic Test: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with postoperative complications in the postanesthesia care unit
Patients will be followed up during their stay in the PACU looking for the appearance of respiratory and hemodynamic complications, temperature disturbances or pain
Measured: 8 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start24 Feb 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,778 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ángel Becerra-Bolaños, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Mekelle University, Jimma University, Haramaya Unversity
- Responsible party
- Sponsor-investigator, Ángel Becerra-Bolaños, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Ataklti Adhanom, MD, Principal investigator, Mekelle UniversitySirak Worku, MD, Principal investigator, Haramaya UniversityBadhaasaa Beyene, MD, Principal investigator, Haramaya UniversityRuth Desta, MD, Principal investigator, Haramaya UniversityEdosa Kejela, MD, Principal investigator, Jimma UniversityÁngel Becerra-Bolaños, MD PhD, Principal investigator, Hospital Universitario de Gran Canaria Doctor NegrínFekrey Berhe Gebru, MD, Principal investigator, Mekelle UniversityFrtuna Zeray, MD, Principal investigator, Mekelle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815510
- Sponsor's protocol ID
- MU-IRB 2418/2024
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentral Observational Prospective Study on Prevalence of Post Anesthesia Care Unit Complications and Associated Factors
- ClinicalTrials.gov ID
- NCT06815510
- Acronym / sponsor ID
- MU-IRB 2418/2024
- Conditions
- Postoperative Care, Complications of Surgical Procedures or Medical Care, Inpatients, Ethiopia, Multicenter Prospective Study
- Keywords
- postoperative complications, postanesthesia care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,778 participants (actual)
- Lead sponsor
- Ángel Becerra-Bolaños, MD PhDUniversity, hospital or other
- Collaborators
- Mekelle University, Jimma University, Haramaya Unversity
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 7 Feb 2025 (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 post-anesthesia care unit (PACU) is a crucial component of the surgical process, providing patients with vital support and monitoring as they recover from anesthesia. Despite advancements in perioperative anesthesia, PACU complications are still common. PACU organization and setup in low-income country like Ethiopia is poor. Previous research's done in some neighbor African countries presumed to have comparable to sociodemographic and economical profile shows varied degree of incidence and prevalence of PACU complication and associated factors. The main objective of this study is to determine the prevalence of PACU complications and its associated factors.
An institutional based prospective cohort study will be conducted in the PACUs of the three selected tertiary care hospitals in Ethiopia from Februery 15, 2025 to June 30, 2025. These data will be compared with those obtained in a tertiary hospital in Spain.
Detailed description
Studying the prevalence and associated factors of PACU complications will be of great academic importance, serving as a valuable reference and resource for further research. It will also help identify risk factors attributable to PACU complications, providing critical insights for hospital administrators and policymakers in making informed decisions about resource allocation and system design to minimize these complications. Understanding the prevalence and potential risk factors of PACU complications is essential for optimizing patient care and improving outcomes. Identified risk factors for postoperative complications in the PACU include female sex, longer duration of anesthesia, and the occurrence of intraoperative complications. This study aims to explore the prevalence of complications in the PACU and identify potential contributing factors, providing valuable insights for healthcare providers and policymakers seeking to improve PACU care. the potential significance and implications of the study findings, includes; Improving the understanding of PACU complications and the associated risk factors, informing the development of targeted prevention and management strategies, enhancing patient safety and quality of care in the perioperative setting and providing a basis for future research and evidence-based clinical guidelines. The study will involve surgical patients admitted to the Post-Anesthesia Care Units (PACUs) of four hospitals: Hiwot Fana Comprehensive Specialized Hospital, Ayder Comprehensive Specialized Hospital, Jimma University Medical Center (Ethiopia) and Hospital Universitario de Gran Canaria Doctor Negrín (Spain). The research will take place from February 15, 2025, to June 30, 2025. Multicenter, prospective, observational cohort study will be conducted reviewing patients admitted to the PACU. Analyzing complications in all patients admitted to the PACUs at the four selected hospitals following surgery under general, regional, or monitored anesthesia will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to the postanesthesia care unit | – | Diagnostic Test: Questionnaire and Physical ExamAdult patients admitted to the postanesthesia care unit following surgery under general, regional, or monitored anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the Post-Anesthesia Care Units (PACUs) following surgery under general, regional, or monitored anesthesia who have signed the informed consent preoperatively will be included in the study.
Key inclusion criteria (1 listed)
- All patients admitted to the Post-Anesthesia Care Units (PACUs) following surgery under general, regional, or monitored anesthesia
Key exclusion criteria (2 listed)
- Patients who are taken directly to the ICU, ward, discharged, or transferred immediately after surgery.
- Patients who do not provide informed consent for enrollment in the study.
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 |
|---|---|---|
| Questionnaire and Physical ExamAlso: Postoperative complications in the PACUPatients will be followed up to find out any of these complications: pulmonary, hemodynamic complications, temperature disturbances, or pain | Diagnostic test | Patients admitted to the postanesthesia care unit |
Primary outcome
Rate of patients with postoperative complications in the postanesthesia care unit
Time frame: 8 postoperative hours
Patients will be followed up during their stay in the PACU looking for the appearance of respiratory and hemodynamic complications, temperature disturbances or pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided. IPD used in the results publication will be shared.
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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.
Ataklti Adhanom, MD principal investigator
Mekelle University
Sirak Worku, MD principal investigator
Haramaya University
Badhaasaa Beyene, MD principal investigator
Haramaya University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Care and Complications of Surgical Procedures or Medical Care, run by Ángel Becerra-Bolaños, MD PhD at 4 sites in 2 countries.
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 2 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: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ethiopia, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with postoperative complications in the postanesthesia care unit (time frame: 8 postoperative hours). 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 25 Sep 2026.