NCT03047148

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,880

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

January 31, 2017

Last Update Submit

May 7, 2018

Conditions

Outcome

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Length of hospital stay

    1 March to 30 November 2017

  • Postoperative mortality

    1 March to 30 November 2017

  • Total in-hospital costs

    1 March to 30 November 2017

Study Arms (2)

Regional Anesthesia

Hospital records from patients who have undergone surgery in regional anesthesia.

Other: Data mining from records

General Anesthesia

Hospital records from patients who have undergone surgery in General anesthesia.

Other: Data mining from records

Interventions

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.

General AnesthesiaRegional Anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • Cases with incomplete quality control assessment data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Institue of Anesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 27992299BACKGROUND

  • 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. doi: 10.1007/s00464-013-3294-8.

    PMID: 24232050BACKGROUND

  • 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.

    PMID: 27852723BACKGROUND

  • 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.

    PMID: 26553953BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 8, 2017

Study Start

January 1, 2018

Primary Completion

April 30, 2018

Study Completion

May 1, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

No IPD planned.

Locations

CH(1)