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

NCT ID: NCT03810391

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-12-31

Brief Summary

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

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.

Conditions

Preoperative Anxiety Score; Total Dose of Butorphanol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Butorphanol

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

physiological saline

Intervention Type: OTHER

intravenous infusion of the same volume of physiological saline

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

Group Type: EXPERIMENTAL

Butorphanol

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

physiological saline

Intervention Type: OTHER

intravenous infusion of the same volume of physiological saline

Interventions

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

Intervention Type: DRUG

physiological saline

intravenous infusion of the same volume of physiological saline

Intervention Type: OTHER

Other Intervention Names

butorphanol tartrate injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yanchao Yang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junchao Zhu, professor

Role: STUDY_DIRECTOR

Shengjing Hospital

Locations

shengjing hospital of China medical university

Shenyang, Liaoning, China

Countries

China

Other Identifiers

Effect of butorphanol

Identifier Type: -

Identifier Source: org_study_id