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Recovery After Upper Extrimety Surgery (Recovery)

14 luglio 2026 aggiornato da: Region Örebro County

The Effect of Anaesthetic Technique and How Anaesthesia is Titrated on the Postoperative Cognitive Performance and General Recovery Following Hand and Upper Extremity Surgery.

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study was designed to investigate the relationship between anesthetic technique, depth of general anesthesia, and postoperative cognitive and overall recovery following elective surgery of the hand or arm.Patients scheduled to receive general anesthesia were randomly allocated using sealed envelopes to one of two general-anesthesia groups. In the BIS-guided group, anesthetic delivery was adjusted using the Bispectral Index, with a target BIS range of 40 to 60. In the clinically guided group, anesthesia was adjusted according to routine clinical indicators, such as blood pressure, heart rate, movement, and other clinical signs. BIS monitoring was also connected in this group, but the values were concealed from the anesthesia personnel and stored for later analysis.General anesthesia was induced with propofol and maintained using sevoiurane and remifentanil according to the study protocol and routine clinical practice. Standard intraoperative monitoring included electrocardiography, noninvasive blood-pressure measurement, oxygen saturation, temperature, and BIS monitoring. Perioperative fluids, treatment of blood-pressure changes, analgesia, and prevention or treatment of postoperative nausea were managed according to the study protocol and usual clinical routines.A separate comparison group consisted of patients whose planned operation was performed using intravenous regional/local anesthesia without general anesthesia. These patients were not randomly assigned to the regional-anesthesia group; their anesthetic method had already been selected as part of their clinical surgical plan.Postoperative recovery was evaluated using the Postoperative Quality of Recovery Scale.

Each participant completed a preoperative baseline assessment, and postoperative assessments were planned at approximately 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery. The scale assessed physiological recovery, pain and postoperative nausea or vomiting, emotional recovery, cognitive performance, activities of daily living, and overall patient-reported recovery.Cognitive assessments included orientation, forward digit recall, backward digit recall, word recall, and word generation.

Postoperative performance was compared with each participant's own preoperative baseline rather than with a single population-level cutoff.The prospect primary assessment was cognitive recovery at 48 hours after surgery. Additional assessments examined recovery at the other postoperative time points, anesthetic exposure, recorded BIS values, perioperative physiological variables, and early postoperative recovery.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

112

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Svezia
      • Örebro, Svezia, 70185
        • Örebro University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: BIS-Guided General Anesthesia
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.
Procedura: 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.
Comparatore attivo: Clinically Guided General Anesthesia
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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participants With Cognitive Recovery at 48 Hours
Lasso di tempo: 48 hours after surgery
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participants With Cognitive Recovery at Other Postoperative Time Points
Lasso di tempo: 20 minutes, 40 minutes, 24 hours, 14 days, and 90 days after surgery
Cognitive recovery was assessed using the Mve PQRS cognitive subtests: orientation, forward digit recall, backward digit recall, word recall, and word generation. Postoperative performance was compared with each participant's own preoperative baseline using the PQRS recovery criteria. The outcome was reported as the number and percentage of participants cognitively recovered at each time point.
20 minutes, 40 minutes, 24 hours, 14 days, and 90 days after surgery
Participants With Overall Postoperative Quality of Recovery
Lasso di tempo: 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Overall recovery was assessed using the applicable domains of the PQRS (physiological recovery, nociception, emotional recovery, cognition, activities of daily living, and overall patient perspective). Participants were classified as having achieved overall recovery when recovery criteria were met in all applicable PQRS domains, based on comparison with the participant's preoperative baseline where applicable. The outcome was reported as the number and percentage of participants achieving overall recovery.
20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Meeting PQRS Physiological Recovery Criteria
Lasso di tempo: Immediately after emergence and at 20 and 40 minutes after surgery
Physiological recovery was assessed from the PQRS physiological domain, which incorporates systolic blood pressure, heart rate, body temperature, respiratory rate, oxygen saturation, oxygen requirement, airway maintenance, agitation, level of consciousness, and ability to follow a simple command. Recovery was determined according to predefined PQRS physiological recovery criteria. Participants were classified as physiologically recovered when all applicable physiological recovery criteria were met. The outcome was reported as the number and percentage of participants meeting PQRS physiological recovery criteria.
Immediately after emergence and at 20 and 40 minutes after surgery
Postoperative Pain Severity Assessed With PQRS
Lasso di tempo: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Pain was rated using the PQRS nociceptive-domain pain item on a five-category scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; and 5, worst imaginable pain. Lower scores indicated less pain. The outcome was reported as pain severity score at each postoperative assessment.
Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Participants Meeting PQRS Emotional Rcovery Criteria
Lasso di tempo: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Emotional recovery was assessed using separate PQRS ratings for depression or sadness and anxiety or nervousness. Each item ranged from 1, not at all, to 5, extreme symptoms, with lower scores indicating better emotional status. Recovery was determined according to PQRS emotional recovery criteria by comparison with the participant's preoperative baseline. The outcome was reported as the number and percentage of participants meeting emotional recovery criteria.
Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Postoperative nausea and vomiting
Lasso di tempo: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Nausea, retching, and vomiting were assessed using the PQRS nociceptive-domain nausea and vomiting item. Scores ranged from 1, no nausea, retching, or vomiting, to 5, continuous retching or vomiting. Lower scores indicated fewer symptoms. Nausea and vomiting severity scores were assessed and summarized at each postoperative time point.
Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Participants Meeting PQRS Activities of Daily Living Recovery Criteria
Lasso di tempo: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Activities of daily living were assessed through the participant's ability to stand, walk, eat and drink, and dress without assistance. Each activity was rated as 1, unable; 2, able with difficulty; or 3, able with ease. Higher scores indicated better function. Recovery was determined according to PQRS activities of daily living recovery criteria by comparison with the participant's preoperative baseline. Participants were classified as recovered when all applicable activities met recovery criteria. The outcome was reported as the number and percentage of participants meeting activities of daily living recovery criteria.
Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Patient-Reported Overall Recovery and Satisfaction Assessed With PQRS
Lasso di tempo: 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
The PQRS overall-perspective domain assessed the perceived effect of surgery on the participant's overall perspective of recovery and satisfaction with anesthesia. Items were rated on five-category scales, with lower scores indicating less negative impact or greater satisfaction. Recovery was determined according to PQRS overall-perspective recovery criteria. The outcome was reported as the number and percentage of participants meeting overall-perspective recovery criteria at each postoperative assessment.
20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Region Örebro County

Investigatori

  • Direttore dello studio: Pether Jildenstål, PhD, Professor, Department of Anesthesia and intensivecare University Hospital Örebro

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 gennaio 2015

Completamento primario (Effettivo)

10 giugno 2024

Completamento dello studio (Effettivo)

10 giugno 2024

Date di iscrizione allo studio

Primo inviato

7 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 luglio 2026

Primo Inserito (Effettivo)

20 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 gennaio 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2014-004024-22
  • 2014/378 (Altro identificatore: Swedish Ethical Review Authority)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared because the original participant consent and ethics documentation did not include a prospective plan for external sharing of participant-level data. Study data are coded and access is restricted to the authorized research team. Results will be reported in aggregated form. Any future request for data access would require separate review and approval by the study sponsor, data controller, and relevant ethics and data-protection authorities.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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