Recovery After Upper Extrimety Surgery

NCT07714928 | Completed

• 2 other identifiers: 2014-004024-222014/378
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Delirium; Postoperative Recovery in Elderly Patients; Postoperative Cognitive Dysfunction (POCD)

Keywords

bispectraindex; sevoflurane; anesthesia; elderly; cognition

Outcome Measures

Primary Outcomes (1)

• Participants With Cognitive Recovery at 48 Hours

  Cognitive recovery was assessed using the cognitive domain of the Postoperative Quality of Recovery Scale (PQRS). The domain included orientation, forward digit recall, backward digit recall, word recall, and word generation. Each participant's postoperative performance was compared with that participant's preoperative baseline using the PQRS recovery criteria. A participant was classiMed as cognitively recovered when all applicable cognitive subtests met the recovery criteria. The outcome was reported as the number and percentage of participants cognitively recovered

  48 hours after surgery

Secondary Outcomes (8)

• Participants With Cognitive Recovery at Other Postoperative Time Points

  20 minutes, 40 minutes, 24 hours, 14 days, and 90 days after surgery

• Participants With Overall Postoperative Quality of Recovery

  20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery

• Meeting PQRS Physiological Recovery Criteria

  Immediately after emergence and at 20 and 40 minutes after surgery

• Postoperative Pain Severity Assessed With PQRS

  Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery

• Participants Meeting PQRS Emotional Rcovery Criteria

  Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery

Study Arms (2)

BIS-Guided General Anesthesia

EXPERIMENTAL

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.

Procedure: BIS-Guided General Anesthesia

Clinically Guided General Anesthesia

ACTIVE COMPARATOR

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.

Procedure: Clinically Guided General Anesthesia

Interventions

BIS-Guided General Anesthesia PROCEDURE

General anesthesia was guided by visible Bispectral Index monitoring. Anesthetic delivery was adjusted to maintain a BIS value between 40 and 60. The protocol included propofol for induction and remifentanil with a volatile anesthetic for maintenance.

BIS-Guided General Anesthesia

Clinically Guided General Anesthesia PROCEDURE

General anesthesia was guided by routine clinical indicators of anesthetic depth. BIS monitoring was recorded, but its values were concealed from the anesthesia personnel and were not used to adjust anesthetic delivery. The anesthetic regimen otherwise followed the same protocol as the BIS-guided group.

Clinically Guided General Anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Örebro University Hospital

Örebro, 70185, Sweden

Location

Related Publications (4)

• Newman S, Wilkinson DJ, Royse CF. Assessment of early cognitive recovery after surgery using the Post-operative Quality of Recovery Scale. Acta Anaesthesiol Scand. 2014 Feb;58(2):185-91. doi: 10.1111/aas.12234. Epub 2013 Nov 22.

  PMID: 24410107 RESULT

• Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.

  PMID: 20601860 RESULT

• Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.

  PMID: 23027226 RESULT

• Jildenstal P, Eriksson J, Warren Stomberg M, Jakobsson JG. Evaluation of the Postoperative Quality of Recovery Scale test and re-test in Swedish among healthy volunteers. F1000Res. 2016 Oct 21;5:2549. doi: 10.12688/f1000research.9740.1. eCollection 2016.

  PMID: 28299175 RESULT

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Study Officials

• Pether Jildenstål, PhD, Professor

  Department of Anesthesia and intensivecare University Hospital Örebro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In the clinically guided general-anesthesia group, BIS values were recorded but concealed from the anesthesia personnel. In the BISguided group, the anesthesia personnel could see the BIS values and use them to guide anesthetic delivery. The anesthesia care provider was therefore aware of the assigned management strategy. Participants were under general anesthesia during the intervention. The available protocol documents do not clearly establish whether investigators or postoperative PQRS outcome assessors remained unaware of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three parallel groups were studied. Patients whose planned surgery was to be performed under intravenous regional anesthesia entered a nonrandomized regional-anesthesia comparison group. Patients scheduled for general anesthesia were randomized using sealed envelopes to either BIS-guided anesthesia, targeting a Bispectral Index value of 40 to 60, or clinically guided anesthesia in which BIS values were recorded but concealed from the anesthesia personnel.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 20, 2026
• Study Start: January 23, 2015
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: July 20, 2026

Record last verified: 2015-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)