- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01717521
Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris
The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device
연구 개요
상태
정황
상세 설명
Researchers at the University of Washington are doing this study to find out if a commonly used anesthetic affects patients Analgesia Nociception Index (level of pain relief) during abdominal hysterectomy under general anesthesia.
The investigators will administer routine anesthesia care including Ketamine, a commonly used anesthetic, during the patients surgery. During the patients surgery, the investigators will monitor the patients level of pain relief using the PhysioDoloris monitor, which monitors the routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is completely non-invasive and collects data from the EKG monitor.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- ASA status I, II, or III
- 18 years or older
- Receiving GA with uncomplicated routine intubation
- Ability to provide informed consent
- English-speaking
Exclusion Criteria:
- Presence of coronary artery disease, cardiac arrhythmias, or ketamine allergy
- Patient refusal
- History of substance abuse
- Patients taking psychotropic and/or opiate drugs
- Having a history of psychiatric diseases or psychological problems
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Mean ANI Changes After Intubation
기간: Before vs after intubation
|
ANI stands for Analgesia Nociception Index.
Its a dimension less number computed by a pain monitor ranging from 0-100.
An index of 100 means absent pain, and the number decreases as pain increases.
ANI was measured pre- and post- Intubation
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Before vs after intubation
|
Mean ANI Changes 3 Min After Ketamine Bolus
기간: Before vs 3 min after Ketamine adminstration
|
ANI was measured pre- and post- i.v.
ketamine administration
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Before vs 3 min after Ketamine adminstration
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Mean ANI Changes 5 Min After Ketamine Bolus
기간: Before vs 5 min after Ketamine adminstration
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ANI was measured pre- and post- i.v.
ketamine administration
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Before vs 5 min after Ketamine adminstration
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Mean ANI Changes After Skin Incision
기간: Before vs after skin incision
|
ANI was measured pre- and post- skin incision
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Before vs after skin incision
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Mean BIS Changes After Intubation
기간: Before vs after intubation
|
BIS was measured pre- and post-intubation. BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
|
Before vs after intubation
|
Mean BIS Changes 3 Min After Ketamine Bolus
기간: Before vs 3 min after Ketamine adminstration
|
BIS was measured pre- and post-Ketamine administration. BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
|
Before vs 3 min after Ketamine adminstration
|
Mean BIS Changes After Skin Incision
기간: Before vs after skin incision
|
BIS was measured pre- and post-skin incision. BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
|
Before vs after skin incision
|
Mean Heart Rate Change After Intubation
기간: Before vs after intubation
|
Heart rate assessed by continuous pulse oximetry.
Heart rate was measured pre- and post-intubation.
|
Before vs after intubation
|
Mean Heart Rate Change 3 Min After Ketamine Bolus
기간: Before vs 3 min after Ketamine adminstration
|
Heart rate was measured pre- and post- Ketamine administration
|
Before vs 3 min after Ketamine adminstration
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Mean Heart Rate Change After Skin Incision
기간: Before vs after skin incision
|
Heart rate was measured pre- and post-skin incision.
|
Before vs after skin incision
|
Change in Mean Arterial Pressure After Intubation
기간: Before vs after intubation
|
MAP or mean arterial pressure is the average blood pressure of an individual and is measured non-invasively during surgery.
MAP was measured pre- and post-intubation.
|
Before vs after intubation
|
Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus
기간: Before vs 3 min after Ketamine adminstration
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MAP was measured pre- and post-ketamine administration
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Before vs 3 min after Ketamine adminstration
|
Mean MAP Changes After Skin Incision
기간: Before vs after skin incision
|
MAP was measured pre- and post- skin incision.
|
Before vs after skin incision
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Average Ketamine Used
기간: Surgery
|
Amount of Ketamine used during surgery
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Surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Laurent Bollag, MD, University of Washington
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
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QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 42398
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