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

Preoperative Anxiety Score Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810391
• Other study ID #: Effect of butorphanol
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 31, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA)?-?

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Preoperative Anxiety Score
• Total Dose of Butorphanol

Intervention

Drug:
• 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

Other:
• physiological saline
intravenous infusion of the same volume of physiological saline

Locations

Country	Name	City	State
China	shengjing hospital of China medical university	Shenyang	Liao Ning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preoperative anxiety score (Amsterdam preoperative anxiety and information scale, APAIS)	evaluate the preoperative anxiety score one day before the surgery, the scale ranges from 0-33. And we define a score of 11 as a cut-off point, the higher the score the more serious the preoperative anxiety is	one day before the surgery
Primary	Ramsay sedation score (Ramsay sedation scale, RSS)	evaluate the Ramsay sedation score 10 min after getting into the operation room and 5, 10, 15, 30min after infusion. The Ramsay sedation scale ranges from 1-6. 1, anxious and agitated or restless or both; 2, cooperative, orientated, and tranquil; 3, responds to commands only; 4, brisk response to a light glabellar tap or auditory stimulus; 5, sluggish response to a light glabellar tap or auditory stimulus; and 6, no response to a light glabellar tap or auditory stimulus. A sedative state with RSS 4 was considered as an adequate level of sedation	during the surgery
Primary	the time when Ramsay sedation score reached 4 points	record the time when Ramsay sedation score reached 4 points. The Ramsay sedation scale ranges from 1-6. 1, anxious and agitated or restless or both; 2, cooperative, orientated, and tranquil; 3, responds to commands only; 4, brisk response to a light glabellar tap or auditory stimulus; 5, sluggish response to a light glabellar tap or auditory stimulus; and 6, no response to a light glabellar tap or auditory stimulus. A sedative state with RSS 4 was considered as an adequate level of sedation	Ramsay sedation score reach 4 points during the surgery
Secondary	vital signs	Record Mean Arterial Pressure(MAP)10 min after getting into the operation room and 5, 10, 15, 30min after infusion	during the surgery
Secondary	The incidence of nausea/ vomiting, dizzy, bradycardia and hypotension	Investigate the incidence of nausea/ vomiting, dizzy, bradycardia and hypotension in the first day after the surgery	in the first day after the surgery
Secondary	post-operative visual analgesia scale scores (VAS)	investigate the VAS every hour till 6 hours and then every 2 hours till 24 hours. The VAS ranges from 1-10. 0 means painless; 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain	within 24 hours after the surgery
Secondary	Vital signs	Record Spo2 10 min after getting into the operation room and 5, 10, 15, 30min after infusion	during the surgery
Secondary	Vital signs	Record Heart Rate(HR) 10 min after getting into the operation room and 5, 10, 15, 30min after infusion	during the surgery