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Recovery After Upper Extrimety Surgery

NCT07714928 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-07-20

No results posted yet for this study

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)

Interventions

PROCEDURE

BIS-Guided General Anesthesia

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.

PROCEDURE

Clinically Guided General Anesthesia

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.

Sponsors & Collaborators

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Pether Jildenstål, PhD, Professor · Department of Anesthesia and intensivecare University Hospital Örebro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-23
Primary Completion
2024-06-10
Completion
2024-06-10

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07714928 on ClinicalTrials.gov