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

Preoperative Anxiety Clinical Trial

Official title:

Using Pre-operative Anxiety Score to Determine the Precise Dose of Butorphanol in Patients Undergoing Orthopedic Procedures: A Double-blinded Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429179
• Other study ID #: the effect of butorphanol
• Status: Completed
• Phase: Phase 2
• Start date: March 5, 2018
• Est. completion date: March 5, 2019

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: March 5, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA ?-?

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Precise Dose of Butorphanol
• Preoperative Anxiety

Intervention

Drug:
• Butorphanol
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

Other:
• Physiological saline
intravenous infusion of the same volume of 0.9% 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 assessed by the Amsterdam preoperative anxiety and information scale (APAIS)".	evaluate the preoperative anxiety score before the surgery, APAIS contains 6 items rated on a five-point Likert scale, which represents two scales: anxiety (items 1, 2, 4, and 5) and need for information (items 3 and 6) Accordingly, the maximal score of the entire APAIS (APAIS-T) is 30 and the one expressing the patient's need for information (APAIS-I) is 10. The maximal score of the two items concerning anxiety about anesthesia (APAIS-A-An) and surgery (APAIS-A-Su) is also 10 each, resulting in a maximal score of 20 for total preoperative anxiety (APAIS-A-T). And APAIS-A-T > 10 was used as a cut-o? to de?ne patients with high anxiety, the higher the score, the more serious the pre-operative anxiety is	before the surgery
Primary	Ramsay Sedation score	evaluate the Ramsay sedation score 10min after getting into the operation room and 5,10,15,30min after infusion.The Ramsay Sedation score 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	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 score 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	Ramsay sedation score reach 4 points during the surgery
Primary	vital signs	Record Mean Arterial Pressure(MAP)10min after getting into the operation room and 5,10,15,30min after infusion	during the surgery
Secondary	vital signs	Record SPO2 10min after getting into the operation room and 5,10,15,30min after infusion	during the surgery
Secondary	Vital signs	Record Heart Rate(HR) 10min 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	first day after the surgery
Secondary	post operative visual analgesia scale scores (VAS)	assess the visual analgesia scale scores (VAS) every hour till 6 h and then every 2 h till 24 h	within 24 hours after the surgery
Secondary	postoperative patient satisfaction	Patient satisfaction was recorded on 5 levels: a) agreeable experience; b) neither pleasant nor unpleasant; c) slightly uncomfortable; d) disagreeable; e) a traumatic experience.	first day after the surgery