OutcomeNCT03047148
Immediate Post-operative Recovery After Regional vs. General Anesthesia
An observational study of Outcome, run by University of Zurich at 1 site in Switzerland.
Trial summary
Early post-anesthesia status of patients emerging from surgery encompasses vital respiratory and hemodynamic parameters as well as subjective signs of well-being such as absence of nausea, vomiting and a low pain level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outcome
- What is being tested?
- Data mining from records
- How many people
- 1,880 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 1 May 2018
- 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: Hospital records from patients after surgery in regional anesthesia that have postoperative quality control data plus a same sized matched pairs control group after general anesthesia.
Who may be able to join
- Records from regional anesthesia cases on adults which have quality control assessment data, plus the same number of matched pairs who had general anesthesia.
Who cannot join
- Cases with incomplete quality control assessment data.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Institue of Anesthesiology
Zurich, Canton of Zurich, 8091
About this study
Official title: Immediate Post-operative Outcome After Regional vs. General Anesthesia
Early post-anesthesia status of patients emerging from surgery encompasses vital respiratory and hemodynamic parameters as well as subjective signs of well-being such as absence of nausea, vomiting and a low pain level. This investigation intends to compare the rate of postoperative complications in the 2 groups from pair matched patient records after regional anesthesia with otherwise similar patients after general anesthesia.
Read the detailed description
It is still unclear whether the immediate post-operative condition of patients after surgery and anesthesia is dependent on the basic anesthesia technique (General vs. regional anesthesia). The patients' post-anesthesia presentation encompasses vital respiratory and hemodynamic parameters as well as subjective signs of well-being such as absence of nausea, vomiting and a low pain level. By pair matching of patient records after regional anesthesia with otherwise similar patients after general anesthesia (control group), the rate of postoperative complications in the 2 groups will be compared. The results of this investigation will help to answer what is the difference in complication rates and wellbeing of patients depending on their previous anesthesia. The results of this study will Show which basic anesthesia technique has more or less early complications.
- Conditions
- Outcome
- Being tested
- Data mining from records
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data mining from recordsOther
The relevant data for this investigation is extracted from the patient records database as well as from the assessment results of the ongoing quality control process that were collected by the nursing staff of the postoperative recovery units.
| Study group | Role | What they receive |
|---|---|---|
| Regional Anesthesia | Hospital records from patients who have undergone surgery in regional anesthesia. Receives: Other: Data mining from records | |
| General Anesthesia | Hospital records from patients who have undergone surgery in General anesthesia. Receives: Other: Data mining from records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications during inhospital stay up to 30 days
Number participants who had one or more cardiovascular events up to discharge or 30 days
Measured: 1 March to 30 November 2017
Postoperative complications during inhospital stay up to 30 days (PONV) - Duration of pain (VAS > 3) episodes in hours; days up to discharge or max. 30 days
Number of PONV episodes up to discharge or max. 30 days Duration of PONV episodes in days; hours up to discharge or max. 30 days
Measured: 1 March to 30 November 2017
Postoperative complications during inhospital stay up to 30 days (pain)
Duration of pain (VAS > 3) episodes in hours; days up to discharge or max. 30 days
Measured: 1 March to 30 November 2017
Secondary outcomes (3)
Length of hospital stay
Length of hospital stay in days up to discharge or max. 30 days
Measured: 1 March to 30 November 2017
Postoperative mortality
In-patient postoperative mortality (yes or no up to 30 days)
Measured: 1 March to 30 November 2017
Total in-hospital costs
Absolute amount per case in CHF according financial department report
Measured: 1 March to 30 November 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Jan 2018
- Primary completion30 Apr 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OutcomeStudies 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
- Retrospective
- Enrolment
- 1,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047148
- Sponsor's protocol ID
- BASEC 2016-01869
- Status last verified
- May 2018
- First submitted
- 31 Jan 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD planned.
Publications
Seims AD, VanHouwelingen L, Mead J, Mao S, Loh A, Sandoval JA, Davidoff AM, Wu J, Wang WC, Fernandez-Pineda I. Operative and Immediate Postoperative Differences Between Traditional Multiport and Reduced Port Laparoscopic Total Splenectomy in Pediatric Patients. J Laparoendosc Adv Surg Tech A. 2017 Feb;27(2):206-210. doi: 10.1089/lap.2016.0309. Epub 2016 Oct 24.
PubMed 27992299Wood SG, Dabu-Bondoc S, Dai F, Mikhael H, Vadivelu N, Roberts KE. Comparison of immediate postoperative pain after transvaginal versus traditional laparoscopic cholecystectomy. Surg Endosc. 2014 Apr;28(4):1141-5. doi: 10.1007/s00464-013-3294-8.
PubMed 24232050Neuman MD, Ellenberg SS, Sieber FE, Magaziner JS, Feng R, Carson JL; REGAIN Investigators. Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial. BMJ Open. 2016 Nov 15;6(11):e013473. doi: 10.1136/bmjopen-2016-013473.
PubMed 27852723Moreira CC, Farber A, Kalish JA, Eslami MH, Didato S, Rybin D, Doros G, Siracuse JJ. The effect of anesthesia type on major lower extremity amputation in functionally impaired elderly patients. J Vasc Surg. 2016 Mar;63(3):696-701. doi: 10.1016/j.jvs.2015.09.050. Epub 2015 Nov 6.
PubMed 26553953
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Post-operative Outcome After Regional vs. General Anesthesia
- ClinicalTrials.gov ID
- NCT03047148
- Acronym / sponsor ID
- BASEC 2016-01869
- Conditions
- Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,880 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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.
Early post-anesthesia status of patients emerging from surgery encompasses vital respiratory and hemodynamic parameters as well as subjective signs of well-being such as absence of nausea, vomiting and a low pain level. This investigation intends to compare the rate of postoperative complications in the 2 groups from pair matched patient records after regional anesthesia with otherwise similar patients after general anesthesia.
Detailed description
It is still unclear whether the immediate post-operative condition of patients after surgery and anesthesia is dependent on the basic anesthesia technique (General vs. regional anesthesia). The patients' post-anesthesia presentation encompasses vital respiratory and hemodynamic parameters as well as subjective signs of well-being such as absence of nausea, vomiting and a low pain level. By pair matching of patient records after regional anesthesia with otherwise similar patients after general anesthesia (control group), the rate of postoperative complications in the 2 groups will be compared. The results of this investigation will help to answer what is the difference in complication rates and wellbeing of patients depending on their previous anesthesia. The results of this study will Show which basic anesthesia technique has more or less early complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional Anesthesia | – | Other: Data mining from recordsHospital records from patients who have undergone surgery in regional anesthesia. |
| General Anesthesia | – | Other: Data mining from recordsHospital records from patients who have undergone surgery in General anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital records from patients after surgery in regional anesthesia that have postoperative quality control data plus a same sized matched pairs control group after general anesthesia.
Key inclusion criteria (1 listed)
- Records from regional anesthesia cases on adults which have quality control assessment data, plus the same number of matched pairs who had general anesthesia.
Key exclusion criteria (1 listed)
- Cases with incomplete quality control assessment data.
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 |
|---|---|---|
| Data mining from recordsThe relevant data for this investigation is extracted from the patient records database as well as from the assessment results of the ongoing quality control process that were collected by the nursing staff of the postoperative recovery units. | Other | General Anesthesia, Regional Anesthesia |
Primary outcome
Postoperative complications during inhospital stay up to 30 days
Time frame: 1 March to 30 November 2017
Number participants who had one or more cardiovascular events up to discharge or 30 days
Postoperative complications during inhospital stay up to 30 days (PONV) - Duration of pain (VAS > 3) episodes in hours; days up to discharge or max. 30 days
Time frame: 1 March to 30 November 2017
Number of PONV episodes up to discharge or max. 30 days Duration of PONV episodes in days; hours up to discharge or max. 30 days
Postoperative complications during inhospital stay up to 30 days (pain)
Time frame: 1 March to 30 November 2017
Duration of pain (VAS > 3) episodes in hours; days up to discharge or max. 30 days
3 secondary outcomes
Length of hospital stay
Time frame: 1 March to 30 November 2017
Postoperative mortality
Time frame: 1 March to 30 November 2017
Total in-hospital costs
Time frame: 1 March to 30 November 2017
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 8 May 2018.
- Background: PubMed 27992299Seims AD, VanHouwelingen L, Mead J, Mao S, Loh A, Sandoval JA, Davidoff AM, Wu J, Wang WC, Fernandez-Pineda I. Operative and Immediate Postoperative Differences Between Traditional Multiport and Reduced Port Laparoscopic Total Splenectomy in Pediatric Patients. J Laparoendosc Adv Surg Tech A. 2017 Feb;27(2):206-210. doi: 10.1089/lap.2016.0309. Epub 2016 Oct 24.
- Background: PubMed 24232050Wood SG, Dabu-Bondoc S, Dai F, Mikhael H, Vadivelu N, Roberts KE. Comparison of immediate postoperative pain after transvaginal versus traditional laparoscopic cholecystectomy. Surg Endosc. 2014 Apr;28(4):1141-5. doi: 10.1007/s00464-013-3294-8.
- Background: PubMed 27852723Neuman MD, Ellenberg SS, Sieber FE, Magaziner JS, Feng R, Carson JL; REGAIN Investigators. Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial. BMJ Open. 2016 Nov 15;6(11):e013473. doi: 10.1136/bmjopen-2016-013473.
- Background: PubMed 26553953Moreira CC, Farber A, Kalish JA, Eslami MH, Didato S, Rybin D, Doros G, Siracuse JJ. The effect of anesthesia type on major lower extremity amputation in functionally impaired elderly patients. J Vasc Surg. 2016 Mar;63(3):696-701. doi: 10.1016/j.jvs.2015.09.050. Epub 2015 Nov 6.
- Individual participant dataSharing planned: No. No IPD planned.
Related trials for Outcome
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Recruiting
At-home Breast Oncology Care Delivered With E-health Solutions
Patient Engagement, Patient Activation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
RecruitingObservational study
Pakistan Arthritis and Connective Tissue Disease Network - Systemic Lupus Erythematosus
SLE - Systemic Lupus Erythematosus
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Outcome, run by University of Zurich at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 8 May 2018. 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 Switzerland. 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?
Postoperative complications during inhospital stay up to 30 days (time frame: 1 March to 30 November 2017). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047148, which also lists 4 linked publications.
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 8 May 2018.