Back to resultsUsing Preoperative Anxiety Score to Determine the Precise Dose of Butorphanol for Sedation
Primary Purpose
Preoperative Anxiety, Precise Dose of Butorphanol
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Butorphanol
Physiological saline
Sponsored by
About this trial
This is an interventional treatment trial for Preoperative Anxiety focused on measuring butorphanol, preoperative anxiety, sedation, recommend dose
Eligibility Criteria
Inclusion Criteria:
- ASA Ⅰ-Ⅱ
- 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
Sites / Locations
- shengjing hospital of China medical university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
High anxiety butorphanol group
High anxiety 0.9% saline group
Low anxiety butorphanol group
Low anxiety 0.9% saline group
Arm Description
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in high anxiety butorphanol group were >10，and 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
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in high anxiety 0.9% saline group were >10, and received an infusion of the same volume of 0.9% saline
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in low anxiety butorphanol group were ≤10,and 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
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in low anxiety 0.9% saline group were ≤10, and received an infusion of the same volume of 0.9% saline
Outcomes
Primary Outcome Measures
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-off to define patients with high anxiety, the higher the score, the more serious the pre-operative anxiety is
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
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
vital signs
Record Mean Arterial Pressure(MAP)10min after getting into the operation room and 5,10,15,30min after infusion
Secondary Outcome Measures
vital signs
Record SPO2 10min after getting into the operation room and 5,10,15,30min after infusion
Vital signs
Record Heart Rate(HR) 10min after getting into the operation room and 5,10,15,30min after infusion
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03429179
Brief Title
Using Preoperative Anxiety Score to Determine the Precise Dose of Butorphanol for Sedation
Official Title
Using Pre-operative Anxiety Score to Determine the Precise Dose of Butorphanol in Patients Undergoing Orthopedic Procedures: A Double-blinded Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
March 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Anxiety, Precise Dose of Butorphanol
Keywords
butorphanol, preoperative anxiety, sedation, recommend dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High anxiety butorphanol group
Arm Type
Experimental
Arm Description
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in high anxiety butorphanol group were >10，and 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
Arm Title
High anxiety 0.9% saline group
Arm Type
Placebo Comparator
Arm Description
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in high anxiety 0.9% saline group were >10, and received an infusion of the same volume of 0.9% saline
Arm Title
Low anxiety butorphanol group
Arm Type
Experimental
Arm Description
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in low anxiety butorphanol group were ≤10,and 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
Arm Title
Low anxiety 0.9% saline group
Arm Type
Placebo Comparator
Arm Description
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in low anxiety 0.9% saline group were ≤10, and received an infusion of the same volume of 0.9% saline
Intervention Type
Drug
Intervention Name(s)
Butorphanol
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Physiological saline
Intervention Description
intravenous infusion of the same volume of 0.9% saline
Primary Outcome Measure Information:
Title
preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS)".
Description
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-off to define patients with high anxiety, the higher the score, the more serious the pre-operative anxiety is
Time Frame
before the surgery
Title
Ramsay Sedation score
Description
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
Time Frame
during the surgery
Title
The time when Ramsay sedation score reached 4 points
Description
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
Time Frame
Ramsay sedation score reach 4 points during the surgery
Title
vital signs
Description
Record Mean Arterial Pressure(MAP)10min after getting into the operation room and 5,10,15,30min after infusion
Time Frame
during the surgery
Secondary Outcome Measure Information:
Title
vital signs
Description
Record SPO2 10min after getting into the operation room and 5,10,15,30min after infusion
Time Frame
during the surgery
Title
Vital signs
Description
Record Heart Rate(HR) 10min after getting into the operation room and 5,10,15,30min after infusion
Time Frame
during the surgery
Title
The incidence of nausea/vomiting dizzy bradycardia and hypotension
Description
investigate the incidence of nausea/vomiting dizzy bradycardia and hypotension in the first day after the surgery
Time Frame
first day after the surgery
Title
post operative visual analgesia scale scores (VAS)
Description
assess the visual analgesia scale scores (VAS) every hour till 6 h and then every 2 h till 24 h
Time Frame
within 24 hours after the surgery
Title
postoperative patient satisfaction
Description
Patient satisfaction was recorded on 5 levels: a) agreeable experience; b) neither pleasant nor unpleasant; c) slightly uncomfortable; d) disagreeable; e) a traumatic experience.
Time Frame
first day after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA Ⅰ-Ⅱ
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhu junchao, doctor
Organizational Affiliation
Shengjing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
shengjing hospital of China medical university
City
Shenyang
State/Province
Liao Ning
ZIP/Postal Code
110004
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
31611935
Citation
Song B, Yang Y, Teng X, Li Y, Bai W, Zhu J. Use of pre-operative anxiety score to determine the precise dose of butorphanol for intra-operative sedation under regional anesthesia: A double-blinded randomized trial. Exp Ther Med. 2019 Nov;18(5):3885-3892. doi: 10.3892/etm.2019.8040. Epub 2019 Sep 23.
Results Reference
derived
Learn more about this trial
Using Preoperative Anxiety Score to Determine the Precise Dose of Butorphanol for Sedation
We'll reach out to this number within 24 hrs