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

China Medical University

Status and phase: Completed; Phase 2

Conditions: Total Dose of Butorphanol; Preoperative Anxiety Score

Treatments: Other: physiological saline; Drug: Butorphanol

Study type: Interventional

Funder types: Other

Identifiers

NCT03810391

Effect of butorphanol

Details and patient eligibility

About

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

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 4 patient groups, including a placebo group

preoperative anxiety and butorphanol

Experimental group

Description:

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

Treatment:

Drug: Butorphanol

preoperative anxiety and saline

Placebo Comparator group

Description:

preoperative anxiety scores of patients in Group B were \>11 and received an infusion of the same volume of physiological saline

Treatment:

Other: physiological saline

non-preoperative anxiety and butorphanol

Experimental group

Description:

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

Treatment:

Drug: Butorphanol

non-preoperative anxiety and saline

Placebo Comparator group

Description:

preoperative anxiety scores of patients in Group D were ≤11 and received an infusion of the same volume of physiological saline

Treatment:

Other: physiological saline