Using Preoperative Anxiety Score to Determine the Total Dose of Butorphanol for Sedation in Patients Undergoing Lower Limb Orthopedic Procedures: A Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- the time when Ramsay sedation score reached 4 points
研究概览
简要总结
Orthopedic surgeries are considered to be discomfortable and the sense of fear and anxiety of patients who already have preoperative anxiety may be aggravated by intraoperative stimulation, which may contribute to postoperative complications. Previous studies have found that high anxiety predicts increased sedative requirements. Therefore, the investigators explored the relationship between anxiety and intraoperative butorphanol requirements and the investigators evaluated the specific sedative requirement which can keep satisfactory sedative state for patients by preoperative anxiety score
详细描述
A total of one hundred and eighteen patients who were to undergoing lower limb orthopedic procedures with spinal anesthesia were selected，the Amsterdam preoperative anxiety and information scale was used to evaluated the degree of preoperative anxiety one day before the surgery. Patients in preoperative anxiety group were randomly allocated to two groups: butorphanol group (Group A) and physiological saline group (Group B); Patients in non-preoperative anxiety group were also randomly allocated to two groups: butorphanol group (Group C) and physiological saline group (Group D). In Group A and Group C, patients received an intravenous loading dose of 15ug/kg butorphanol 5 min before starting the surgery, then followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion until the Ramsay sedation score reached 4 points, Group B and Group D received an infusion of the same volume of physiological saline. The sedation scores were recorded 10 min after getting into the operation room and 5, 10, 15, 30min after infusion of butorphanol or physiological saline. The duration when Ramsay sedation score reached 4 points in Group A and C, adverse events and post-operative visual analgesia scale scores were also recorded and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ
- •18-75 years
- •Scheduled for elective low limb orthopaedic procedures under spinal anesthesia
排除标准
- •central system disease
- •cardiovascular disease
- •autonomic nervous system disease
- •long term use of analgesic, sedative, and anti-anxiety drugs
- •psychosis
- •a patient with a language communication disorder not willing to cooperate with the experimenter
研究组 & 干预措施
preoperative anxiety and butorphanol
preoperative anxiety scores of patients in Group A were >11 and received an intravenous loading dose of 15ug/kg butorphanol 5 min before starting the surgery, then followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion until the Ramsay sedation score reached 4 points
干预措施: Butorphanol (Drug)
preoperative anxiety and saline
preoperative anxiety scores of patients in Group B were >11 and received an infusion of the same volume of physiological saline
干预措施: physiological saline (Other)
non-preoperative anxiety and butorphanol
preoperative anxiety scores of patients in Group C were ≤ 11 and received an intravenous loading dose of 15ug/kg butorphanol 5 min before starting the surgery, then followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion until the Ramsay sedation score reached 4 points
干预措施: Butorphanol (Drug)
non-preoperative anxiety and saline
preoperative anxiety scores of patients in Group D were ≤11 and received an infusion of the same volume of physiological saline
干预措施: physiological saline (Other)
结局指标
主要结局
the time when Ramsay sedation score reached 4 points
时间窗: Ramsay sedation score reach 4 points during the surgery
record the time when Ramsay sedation score reached 4 points. The Ramsay sedation scale ranges from 1-6. 1, anxious and agitated or restless or both; 2, cooperative, orientated, and tranquil; 3, responds to commands only; 4, brisk response to a light glabellar tap or auditory stimulus; 5, sluggish response to a light glabellar tap or auditory stimulus; and 6, no response to a light glabellar tap or auditory stimulus. A sedative state with RSS 4 was considered as an adequate level of sedation
preoperative anxiety score (Amsterdam preoperative anxiety and information scale, APAIS)
时间窗: one day before the surgery
evaluate the preoperative anxiety score one day before the surgery, the scale ranges from 0-33. And we define a score of 11 as a cut-off point, the higher the score the more serious the preoperative anxiety is
Ramsay sedation score (Ramsay sedation scale, RSS)
时间窗: during the surgery
evaluate the Ramsay sedation score 10 min after getting into the operation room and 5, 10, 15, 30min after infusion. The Ramsay sedation scale ranges from 1-6. 1, anxious and agitated or restless or both; 2, cooperative, orientated, and tranquil; 3, responds to commands only; 4, brisk response to a light glabellar tap or auditory stimulus; 5, sluggish response to a light glabellar tap or auditory stimulus; and 6, no response to a light glabellar tap or auditory stimulus. A sedative state with RSS 4 was considered as an adequate level of sedation
次要结局
- Vital signs(during the surgery)
- vital signs(during the surgery)
- The incidence of nausea/ vomiting, dizzy, bradycardia and hypotension(in the first day after the surgery)
- post-operative visual analgesia scale scores (VAS)(within 24 hours after the surgery)
研究者
Yanchao Yang
Principal Investigator
Shengjing Hospital