Elder Surgery - Functional Recovery Following Beta Blockade
This study proposes a prospective randomized study of elders undergoing elective major abdominal surgery to assess recovery following a unique anesthetic regimen incorporating a adrenergic receptor antagonist. The purposes of this study are to:
- to determine if using atenolol, a beta-blocker drug commonly used to treat high blood pressure and heart disease, as part of your anesthetic regimen will decrease complications that sometimes occur in elderly patients who are undergoing surgery and being given anesthesia.
- to see if it improves or quickens your recovery from anesthesia and surgery.
- to help investigators design better ways to administer anesthesia during surgery, especially in elderly patients, so that the complications and the time to recover from surgery and anesthesia can be decreased.
연구 개요
상세 설명
Increasing numbers of aged patients with multiple chronic diseases are undergoing major surgery. In the first third the last century, surgery was considered a desperate measure and patients greater than 50 years of age were felt incapable of sustaining the rigors of an inguinal hernia repair. Advances in anesthesia during the last century have allowed surgeons to develop an extraordinary array of procedures with excellent outcomes. Over 5.5 million patients aged 60 and over had major procedures in 1994. Centenarians routinely undergo surgical procedures.
Notwithstanding the enthusiasm for surgical treatments, morbidity, mortality, and recovery times for elderly patients are still substantially greater than for younger patients. Some morbidities, such as postoperative delirium and cognitive dysfunction appear to predominantly affect elderly patients. In a previous study, Dr. Valerie Lawrence, a co-investigator on this proposal, demonstrated that recovery from major surgery, as measured by the ability to accomplish standard activities of daily living, takes an average of 6 weeks while more complicated instrumental activities of daily living take an average of 3 months to return to baseline in elderly surgical patients. These data have profound implications for initiatives to control length of hospital stay, utilization of resources and costs of care. Evidence suggests that family members are requiring extra time off work to care for family members discharged earlier from hospitals.
Published reports and our preliminary data support the notion that intraoperative administration of adrenergic receptor antagonists (blockers) will improve functional recovery following surgery under general anesthesia. There is value in targeting functional status for elders undergoing surgery, because there is a direct relationship between functional status and utilization of health resources. Maximizing postoperative recovery, as opposed to minimizing morbidity and mortality, associated with surgical interventions in the elderly is consistent with the goal of prolonging "active life expectancy" expounded by Healthy People 2002.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
-
-
Minnesota
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Rochester, Minnesota, 미국, 55905
- The Mayo Clinic
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New York
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, 미국, 10016
- NYU School of Medicine
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients 65 years of age or older
- Patients undergoing elective major abdominal surgery (including but not limited to bowel, gastric, esophageal, pancreatic, gynecologic, urologic, and major intra-abdominal vascular procedures).
- Procedures requiring general anesthesia
- Laparoscopic-assisted major abdominal procedures
- Procedures requiring a 2-3 day postoperative stay will be included.
Exclusion Criteria:
- Unable to give informed consent to participate
- Folstein Mini-Mental State Examination Score < 17
- Gastrostomy tube placement
- Laparoscopic cholecystectomy, laparoscopic Nissen fundoplication, or any type of Hernia repair
- Appendectomy
- Emergency surgery
- Contraindications to adrenergic antagonists (third-degree heart block, decompensated congestive heart failure, active bronchospasm)
- Surgery within the previous month
- Major systemic infections
- Allergies to or incompatibilities with any drug used in this study
- Principle language other than English or Spanish
- Residence greater than 100 miles away from Manhattan
- Chronic debilitated state from which significant functional improvement following surgery is not anticipated (e.g., some nursing home residents, known metastatic cancer with poor prognosis)
- Chronic opioid usage
- Immunosuppression (subsequent opportunistic infections may obscure postoperative recovery).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Atenolol
Atenolol given prior to and for up to 7 days after surgery
|
Patients with a standing prescription for β-blockers will be continued on that medication.
Pts not currently receiving a beta blocker will be given 50mg of atenolol on the morning of surgery, 50-100mg, twice per day, on the first postoperative day until postoperative day 7.
다른 이름들:
|
|
간섭 없음: routine care
routine clinical care
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Long Term Functional Recovery
기간: at 3 weeks after surgery
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self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL).
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at 3 weeks after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Timed Up and Go test
기간: preoperatively
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assesses basic functional mobility
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preoperatively
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Timed Up and Go test
기간: once at 7-10 days postoperatively
|
assesses basic functional mobility
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once at 7-10 days postoperatively
|
|
Timed Up and Go test
기간: 1 month postoperatively
|
assesses basic functional mobility
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1 month postoperatively
|
|
Timed Up and Go test
기간: 3 months postoperatively
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assesses basic functional mobility
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3 months postoperatively
|
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Timed Up and Go test
기간: 6 months postoperatively
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assesses basic functional mobility
|
6 months postoperatively
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Hand grip strength
기간: preoperatively
|
performance-based measure of upper extremity strength.
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preoperatively
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Hand grip strength
기간: once at 7-10 days postoperatively
|
performance-based measure of upper extremity strength.
|
once at 7-10 days postoperatively
|
|
Hand grip strength
기간: 1 month postoperatively
|
performance-based measure of upper extremity strength.
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1 month postoperatively
|
|
Hand grip strength
기간: 3 months postoperatively
|
performance-based measure of upper extremity strength.
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3 months postoperatively
|
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Hand grip strength
기간: 6 months postoperatively
|
performance-based measure of upper extremity strength.
|
6 months postoperatively
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jefrey H. Silverstein, MD, Icahn School of Medicine at Mount Sinai
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- GCO 00-0100
- AG018772 (기타 보조금/기금 번호: National Institute on Aging (NIA))
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. .
Atenolol에 대한 임상 시험
-
Seoul National University Hospital완전한
-
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-
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-
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-
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-
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