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

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

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

Study Overview

• Status: Completed
• Conditions: Preoperative Anxiety Score; Total Dose of Butorphanol
• Intervention / Treatment: Drug: Butorphanol; Other: physiological saline

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• 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:

• 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

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: preoperative anxiety and 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	Drug: Butorphanol; 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; Other Names: butorphanol tartrate injection
Placebo Comparator: preoperative anxiety and saline; preoperative anxiety scores of patients in Group B were >11 and received an infusion of the same volume of physiological saline	Other: physiological saline; intravenous infusion of the same volume of physiological saline
Experimental: non-preoperative anxiety and 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	Drug: Butorphanol; 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; Other Names: butorphanol tartrate injection
Placebo Comparator: non-preoperative anxiety and saline; preoperative anxiety scores of patients in Group D were ≤11 and received an infusion of the same volume of physiological saline	Other: physiological saline; intravenous infusion of the same volume of physiological saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Study Director: Junchao Zhu, professor, Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: January 13, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: sedation; preoperative anxiety; recommend dose; Butorphanol
• 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: 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