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

Study Overview
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Brief Summary
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Pre-operative anxiety usually lead to increased anesthetics during the surgery. The precise sedative requirement which can keep adequate sedative state and avoid adverse effects caused by excessive drugs still needs further study. Therefore, our purpose was to confirm the sedative effect of butorphanol and to explore the relationship between pre-operative anxiety and intra-operative butorphanol requirement to evaluate the precise sedative requirement which can keep adequate sedation for patients by pre-operative anxiety score.

Detailed Description
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A total of 142 patients (aged 18-75 years) who were scheduled for elective low limb orthopedic procedures under spinal anesthesia were included in this study. Patients were divided into two groups based on pre-operative anxiety score evaluated by the Amsterdam pre-operative anxiety and information scale before the surgery. And intramuscular midazolam 0.05mg/kg as a premedication in preoperative room was given to patients before shifting into operation room. Patients in each group were randomly divided into butorphanol group and 0.9% saline group. The sedation score, the duration of reaching adequate sedation state and postoperative recovery were recorded.

Official Title
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Using Pre-operative Anxiety Score to Determine the Precise Dose of Butorphanol in Patients Undergoing Orthopedic Procedures: A Double-blinded Randomized Trial

Conditions
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Preoperative Anxiety, Precise 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: ASA Ⅰ-Ⅱ age 18-75 years surgical operation of lower extremities in orthopedics no contraindication of epidural anesthesia Exclusion Criteria: with central system disease with cardiovascular disease with autonomic nervous system disease long term use of analgesic drugs ,sedative drugs,and anti-anxiety drugs language barrier unwilling 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High anxiety butorphanol group<br>preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in high anxiety butorphanol group were >10，and 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 | Drug: Butorphanol<br>* 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<br>|
| Placebo Comparator: High anxiety 0.9% saline group<br>preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in high anxiety 0.9% saline group were >10, and received an infusion of the same volume of 0.9% saline | Other: Physiological saline<br>* intravenous infusion of the same volume of 0.9% saline<br>|
| Experimental: Low anxiety butorphanol group<br>preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in low anxiety butorphanol group were ≤10,and 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 | Drug: Butorphanol<br>* 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<br>|
| Placebo Comparator: Low anxiety 0.9% saline group<br>preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in low anxiety 0.9% saline group were ≤10, and received an infusion of the same volume of 0.9% saline | Other: Physiological saline<br>* intravenous infusion of the same volume of 0.9% saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS). | evaluate the preoperative anxiety score before the surgery, APAIS contains 6 items rated on a five-point Likert scale, which represents two scales: anxiety (items 1, 2, 4, and 5) and need for information (items 3 and 6) Accordingly, the maximal score of the entire APAIS (APAIS-T) is 30 and the one expressing the patient's need for information (APAIS-I) is 10. The maximal score of the two items concerning anxiety about anesthesia (APAIS-A-An) and surgery (APAIS-A-Su) is also 10 each, resulting in a maximal score of 20 for total preoperative anxiety (APAIS-A-T). And APAIS-A-T > 10 was used as a cut-oﬀ to deﬁne patients with high anxiety, the higher the score, the more serious the pre-operative anxiety is | before the surgery | 
| Ramsay Sedation score | evaluate the Ramsay sedation score 10min after getting into the operation room and 5,10,15,30min after infusion.The Ramsay Sedation score 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 | 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 score 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 | Ramsay sedation score reach 4 points during the surgery | 
| vital signs | Record Mean Arterial Pressure(MAP)10min after getting into the operation room and 5,10,15,30min after infusion | during the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs | Record SPO2 10min after getting into the operation room and 5,10,15,30min after infusion | during the surgery | 
| Vital signs | Record Heart Rate(HR) 10min 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 | first day after the surgery | 
| post operative visual analgesia scale scores (VAS) | assess the visual analgesia scale scores (VAS) every hour till 6 h and then every 2 h till 24 h | within 24 hours after the surgery | 
| postoperative patient satisfaction | Patient satisfaction was recorded on 5 levels: a) agreeable experience; b) neither pleasant nor unpleasant; c) slightly uncomfortable; d) disagreeable; e) a traumatic experience. | first day after 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