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Recovery After Upper Extrimety Surgery (Recovery)

2026년 7월 14일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

112

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 스웨덴
      • Örebro, 스웨덴, 70185
        • Örebro University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: 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.
활성 비교기: 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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Participants With Cognitive Recovery at 48 Hours
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Participants With Cognitive Recovery at Other Postoperative Time Points
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Region Örebro County

수사관

  • 연구 책임자: Pether Jildenstål, PhD, Professor, Department of Anesthesia and intensivecare University Hospital Örebro

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 1월 23일

기본 완료 (실제)

2024년 6월 10일

연구 완료 (실제)

2024년 6월 10일

연구 등록 날짜

최초 제출

2026년 7월 7일

QC 기준을 충족하는 최초 제출

2026년 7월 14일

처음 게시됨 (실제)

2026년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 14일

마지막으로 확인됨

2015년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2014-004024-22
  • 2014/378 (기타 식별자: Swedish Ethical Review Authority)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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