Clinical trial NCT03810391: Using Preoperative Anxiety Score to Determine the Total Dose of Butorphanol for Sedation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preoperative Anxiety Score
Total Dose of Butorphanol
Keywords: Butorphanol
preoperative anxiety
sedation
recommend dose
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 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 , Group B and Group D received an infusion of the same volume of physiological saline
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: preoperative anxiety score (Amsterdam preoperative anxiety and information scale, APAIS)
timeFrame: one day before the surgery
measure: Ramsay sedation score (Ramsay sedation scale, RSS)
timeFrame: during the surgery
measure: the time when Ramsay sedation score reached 4 points
timeFrame: Ramsay sedation score reach 4 points during the surgery
Secondary outcomes:
measure: vital signs
timeFrame: during the surgery
measure: The incidence of nausea/ vomiting, dizzy, bradycardia and hypotension
timeFrame: in the first day after the surgery
measure: post-operative visual analgesia scale scores (VAS)
timeFrame: within 24 hours after the surgery
measure: Vital signs
timeFrame: during the surgery
measure: Vital signs
timeFrame: during 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: Junchao Zhu, professor
role: STUDY_DIRECTOR
References: