Using Preoperative Anxiety Score to Determine the Total Dose of Butorphanol for Sedation
- Conditions
- Total Dose of ButorphanolPreoperative Anxiety Score
- Interventions
- Other: physiological saline
- Registration Number
- NCT03810391
- Lead Sponsor
- Shengjing Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ
- 18-75 years
- Scheduled for elective low limb orthopaedic procedures under spinal anesthesia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description preoperative anxiety and saline physiological saline preoperative anxiety scores of patients in Group B were \>11 and received an infusion of the same volume of physiological saline non-preoperative anxiety and saline physiological saline preoperative anxiety scores of patients in Group D were ≤11 and received an infusion of the same volume of physiological saline preoperative anxiety and butorphanol 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 non-preoperative anxiety and butorphanol 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
- Primary Outcome Measures
Name Time Method the time when Ramsay sedation score reached 4 points 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) 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) 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
- Secondary Outcome Measures
Name Time Method Vital signs during the surgery Record Heart Rate(HR) 10 min after getting into the operation room and 5, 10, 15, 30min after infusion
vital signs during the surgery Record Mean Arterial Pressure(MAP)10 min after getting into the operation room and 5, 10, 15, 30min after infusion
The incidence of nausea/ vomiting, dizzy, bradycardia and hypotension in the first day after the surgery Investigate 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 investigate the VAS every hour till 6 hours and then every 2 hours till 24 hours. The VAS ranges from 1-10. 0 means painless; 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain
Trial Locations
- Locations (1)
shengjing hospital of China medical university
🇨🇳Shenyang, Liao Ning, China