CompletedNot Applicable

Recovery After Upper Extrimety Surgery

Sweden112 participantsStarted 2015-01-23

Plain-language summary

The goal of this randomized clinical trial is to determine whether Bispectral Index (BIS)-guided general anesthesia improves postoperative cognitive recovery and overall quality of recovery in adults undergoing elective hand or arm surgery. The main questions it aims to answer are: Does BIS-guided anesthesia improve postoperative cognitive recovery compared with general anesthesia guided by routine clinical signs? Does BIS-guided anesthesia improve overall postoperative recovery, as measured by the Postoperative Quality of Recovery Scale (PQRS)? Researchers will compare patients receiving BIS-guided general anesthesia with patients receiving clinically guided general anesthesia, in which the BIS monitor records data but the displayed values are concealed from the anesthesia team, to determine whether BIS-guided anesthetic management improves postoperative recovery. An additional comparison group will consist of patients undergoing surgery under intravenous regional anesthesia without general anesthesia. Participants will: undergo elective hand or arm surgery; receive either BIS-guided or clinically guided general anesthesia, or intravenous regional anesthesia without general anesthesia; complete PQRS assessments before surgery and at multiple postoperative time points, including follow-up for up to three months.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 65 years or older. * Scheduled to undergo hand or arm surgery using either intravenous regional anesthesia or general anesthesia. * Able to understand the study information and provide informed consent. * Able to complete the Postoperative Quality of Recovery Scale assessments and cognitive tests. Exclusion Criteria: * Inability to complete the recovery or cognitive assessments. * Deafness or hearing impairment that prevented completion of the assessments. * Bispectral Index monitoring could not be applied or used because of technical or surgical reasons. * Expected duration of surgery of less than 30 minutes or more than 4 hours. * Allergy to nuts or soybeans in participants scheduled to receive general anesthesia. * Pregnancy. * Substance abuse.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participants With Cognitive Recovery at 48 Hours

Timeframe: 48 hours after surgery

Trial details

NCT IDNCT07714928

SponsorRegion Örebro County

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-10

View on ClinicalTrials.gov More Postoperative Delirium trials