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

NCT03429179 | Completed Phase 2 DMC

• 1 other identifier: the effect of butorphanol
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Anxiety; Precise Dose of Butorphanol

Keywords

butorphanol; preoperative anxiety; sedation; recommend dose

Outcome Measures

Primary Outcomes (4)

• 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

  before the surgery

• 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

• 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

• 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 Outcomes (5)

• vital signs

  during the surgery

• Vital signs

  during the surgery

• The incidence of nausea/vomiting dizzy bradycardia and hypotension

  first day after the surgery

• post operative visual analgesia scale scores (VAS)

  within 24 hours after the surgery

• postoperative patient satisfaction

  first day after the surgery

Study Arms (4)

High anxiety butorphanol group

EXPERIMENTAL

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

Drug: Butorphanol

High anxiety 0.9% saline group

PLACEBO COMPARATOR

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

Other: Physiological saline

Low anxiety butorphanol group

EXPERIMENTAL

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

Drug: Butorphanol

Low anxiety 0.9% saline group

PLACEBO COMPARATOR

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

Other: Physiological saline

Interventions

Butorphanol DRUG

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

High anxiety butorphanol group; Low anxiety butorphanol group

Physiological saline OTHER

intravenous infusion of the same volume of 0.9% saline

High anxiety 0.9% saline group; Low anxiety 0.9% saline group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Ⅰ-Ⅱ
• age 18-75 years
• surgical operation of lower extremities in orthopedics
• no contraindication of epidural anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

shengjing hospital of China medical university

Shenyang, Liaoning, 110004, China

Location

Related Publications (1)

• 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.

  PMID: 31611935 DERIVED

MeSH Terms

Interventions

Butorphanol

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Zhu junchao, doctor

  Shengjing Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2018
• First Posted: February 12, 2018
• Study Start: March 5, 2018
• Primary Completion: February 20, 2019
• Study Completion: March 5, 2019
• Last Updated: May 15, 2019

Record last verified: 2019-03

Locations

CN (1)