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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
intravenous loading dose of 15ug/kg butorphanol,and followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion until the Ramsay sedation score reached 4 points
intravenous infusion of the same volume of physiological saline
shengjing hospital of China medical university
Shenyang, Liaoning, China
preoperative anxiety score (Amsterdam preoperative anxiety and information scale, APAIS)
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
Time frame: one day before the surgery
Ramsay sedation score (Ramsay sedation scale, RSS)
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
Time frame: during the surgery
the time when Ramsay sedation score reached 4 points
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
Time frame: Ramsay sedation score reach 4 points during the surgery
vital signs
Record Mean Arterial Pressure(MAP)10 min after getting into the operation room and 5, 10, 15, 30min after infusion
Time frame: during the surgery
The incidence of nausea/ vomiting, dizzy, bradycardia and hypotension
Investigate the incidence of nausea/ vomiting, dizzy, bradycardia and hypotension in the first day after the surgery
Time frame: in the first day after the surgery
post-operative visual analgesia scale scores (VAS)
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
Time frame: within 24 hours after the surgery
Vital signs
Record Spo2 10 min after getting into the operation room and 5, 10, 15, 30min after infusion
Time frame: during the surgery
Vital signs
Record Heart Rate(HR) 10 min after getting into the operation room and 5, 10, 15, 30min after infusion
Time frame: during the surgery
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