Clinical trial NCT03429179: Using Preoperative Anxiety Score to Determine the Precise Dose of Butorphanol for Sedation
Official title: Using Pre-operative Anxiety Score to Determine the Precise Dose of Butorphanol in Patients Undergoing Orthopedic Procedures: A Double-blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preoperative Anxiety
Precise Dose of Butorphanol
Keywords: butorphanol
preoperative anxiety
sedation
recommend dose
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS)".
timeFrame: before the surgery
measure: Ramsay Sedation score
timeFrame: during the surgery
measure: The time when Ramsay sedation score reached 4 points
timeFrame: Ramsay sedation score reach 4 points during the surgery
measure: vital signs
timeFrame: during the surgery
Secondary outcomes:
measure: vital signs
timeFrame: during the surgery
measure: Vital signs
timeFrame: during the surgery
measure: The incidence of nausea/vomiting dizzy bradycardia and hypotension
timeFrame: first day after the surgery
measure: post operative visual analgesia scale scores (VAS)
timeFrame: within 24 hours after the surgery
measure: postoperative patient satisfaction
timeFrame: first day after the surgery
Other outcomes:
Locations:
city: Shenyang
country: China
facility: shengjing hospital of China medical university
state: Liao Ning
Study officials:
affiliation: Shengjing Hospital
name: Zhu junchao, doctor
role: STUDY_DIRECTOR
References:
citation: 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.