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

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

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.

Study Overview

• Status: Completed
• Conditions: Preoperative Anxiety; Precise Dose of Butorphanol
• Intervention / Treatment: Drug: Butorphanol; Other: Physiological saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Liao Ning
    • Shenyang, Liao Ning, China, 110004
      • Shengjing Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High anxiety butorphanol group; 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; 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
Placebo Comparator: High anxiety 0.9% saline group; 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; intravenous infusion of the same volume of 0.9% saline
Experimental: Low anxiety butorphanol group; 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; 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
Placebo Comparator: Low anxiety 0.9% saline group; 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; intravenous infusion of the same volume of 0.9% saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Study Director: Zhu junchao, doctor, Shengjing Hospital

Publications and helpful links

General Publications

• Song B, Yang Y, Teng X, Li Y, Bai W, Zhu J. Use of pre-operative anxiety score to determine the precise dose of butorphanol for intra-operative sedation under regional anesthesia: A double-blinded randomized trial. Exp Ther Med. 2019 Nov;18(5):3885-3892. doi: 10.3892/etm.2019.8040. Epub 2019 Sep 23.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): February 20, 2019
• Study Completion (Actual): March 5, 2019

Study Registration Dates

• First Submitted: January 20, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: sedation; preoperative anxiety; butorphanol; recommend dose
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Respiratory System Agents; Antitussive Agents; Butorphanol
• Other Study ID Numbers: the effect of butorphanol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No