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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03047148
Other study ID # BASEC 2016-01869
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date May 1, 2018

Study information

Verified date May 2018
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1880
Est. completion date May 1, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Records from regional anesthesia cases on adults which have quality control assessment data, plus the same number of matched pairs who had general anesthesia.

Exclusion Criteria:

- Cases with incomplete quality control assessment data.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data mining from records
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.

Locations

Country Name City State
Switzerland University Hospital Zurich, Institue of Anesthesiology Zurich ZH

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Moreira 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. — View Citation

Neuman 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. — View Citation

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. — View Citation

Wood 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications during inhospital stay up to 30 days Number participants who had one or more cardiovascular events up to discharge or 30 days 1 March to 30 November 2017
Primary 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 1 March to 30 November 2017
Primary 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 1 March to 30 November 2017
Secondary Length of hospital stay Length of hospital stay in days up to discharge or max. 30 days 1 March to 30 November 2017
Secondary Postoperative mortality In-patient postoperative mortality (yes or no up to 30 days) 1 March to 30 November 2017
Secondary Total in-hospital costs Absolute amount per case in CHF according financial department report 1 March to 30 November 2017
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