Using Preoperative Anxiety Score to Determine the Total Dose of Butorphanol for Sedation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Preoperative Anxiety Score, Total Dose of Butorphanol

Intervention / Treatment
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* Drug: Butorphanol
* Other: physiological saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ 18-75 years Scheduled for elective low limb orthopaedic procedures under spinal anesthesia Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 mins before starting the surgery, then followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion when the Ramsay sedation score (RSS) reached 4 , Group B and Group D received an infusion of the same volume of physiological saline
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preoperative anxiety and butorphanol<br>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 | Drug: Butorphanol<br>* 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<br>* Other names: butorphanol tartrate injection;|
| Placebo Comparator: preoperative anxiety and saline<br>preoperative anxiety scores of patients in Group B were >11 and received an infusion of the same volume of physiological saline | Other: physiological saline<br>* intravenous infusion of the same volume of physiological saline<br>|
| Experimental: non-preoperative anxiety and butorphanol<br>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 | Drug: Butorphanol<br>* 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<br>* Other names: butorphanol tartrate injection;|
| Placebo Comparator: non-preoperative anxiety and saline<br>preoperative anxiety scores of patients in Group D were ≤11 and received an infusion of the same volume of physiological saline | Other: physiological saline<br>* intravenous infusion of the same volume of physiological saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Ramsay sedation score reach 4 points during the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs | Record Mean Arterial Pressure(MAP)10 min after getting into the operation room and 5, 10, 15, 30min after infusion | 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 | 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 | 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 | during the surgery | 
| Vital signs | Record Heart Rate(HR) 10 min after getting into the operation room and 5, 10, 15, 30min after infusion | during the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Butorphanol, preoperative anxiety, sedation, recommend dose