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

China Medical University

Status and phase: Completed; Phase 2

Conditions: Precise Dose of Butorphanol; Preoperative Anxiety

Treatments: Other: Physiological saline; Drug: Butorphanol

Study type: Interventional

Funder types: Other

Identifiers

NCT03429179

the effect of butorphanol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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155 participants in 4 patient groups, including a placebo group

High anxiety butorphanol group

Experimental group

Description:

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

Treatment:

Drug: Butorphanol

High anxiety 0.9% saline group

Placebo Comparator group

Description:

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

Treatment:

Other: Physiological saline

Low anxiety butorphanol group

Experimental group

Description:

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

Treatment:

Drug: Butorphanol

Low anxiety 0.9% saline group

Placebo Comparator group

Description:

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

Treatment:

Other: Physiological saline