Recovery After Upper Extrimety Surgery
Key facts
- Who runs it
- Region Örebro County
- Where
- Sweden1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 112 people enrolled
- Started
- 23 Jan 2015
- Ended
- 10 Jun 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- BIS-Guided General Anesthesia
- Clinically Guided General Anesthesia
- Record updated
- 20 July 2026
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Deafness or hearing impairment that prevented completion of the assessments
- Allergy to nuts or soybeans in participants scheduled to receive general anesthesia
- Inability to complete the recovery or cognitive assessments
- Pregnancy
- Substance abuse
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- BIS-Guided General AnesthesiaTreatment being tested
Participants scheduled for general anesthesia were randomized to anesthesia guided by visible Bispectral Index monitoring. The anesthesia team adjusted anesthetic delivery using a target BIS range of 40 to 60. General anesthesia was induced with propofol and maintained with a volatile anesthetic and remifentanil according to the study protocol.
- Clinically Guided General AnesthesiaExisting treatment, for comparison
Participants scheduled for general anesthesia were randomized to anesthesia guided by routine clinical signs. BIS monitoring was connected and recorded throughout anesthesia, but the BIS display was concealed from the anesthesia personnel and was not used to guide anesthetic delivery. The anesthetic regimen otherwise followed the same study protocol as the BIS-guided group.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of Anaesthetic Technique and How Anaesthesia is Titrated on the Postoperative Cognitive Performance and General Recovery Following Hand and Upper Extremity Surgery.
- Record updated
- 20 July 2026