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.
Inclusion Criteria:
Exclusion Criteria:
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.
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.
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.
Örebro, 70185, Sweden
Recovery From General Anesthesia
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