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

NCT03810391 | Completed Phase 2 DMC

• 1 other identifier: Effect of butorphanol
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Conditions

Preoperative Anxiety Score; Total Dose of Butorphanol

Keywords

Butorphanol; preoperative anxiety; sedation; recommend dose

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• vital signs

  during the surgery

• The incidence of nausea/ vomiting, dizzy, bradycardia and hypotension

  in the first day after the surgery

• post-operative visual analgesia scale scores (VAS)

  within 24 hours after the surgery

• Vital signs

  during the surgery

• Vital signs

  during the surgery

Study Arms (4)

preoperative anxiety and butorphanol

EXPERIMENTAL

preoperative anxiety scores of patients in Group A were \>11 and 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

Drug: Butorphanol

preoperative anxiety and saline

PLACEBO COMPARATOR

preoperative anxiety scores of patients in Group B were \>11 and received an infusion of the same volume of physiological saline

Other: physiological saline

non-preoperative anxiety and butorphanol

EXPERIMENTAL

preoperative anxiety scores of patients in Group C were ≤ 11 and 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

Drug: Butorphanol

non-preoperative anxiety and saline

PLACEBO COMPARATOR

preoperative anxiety scores of patients in Group D were ≤11 and received an infusion of the same volume of physiological saline

Other: physiological saline

Interventions

Butorphanol DRUG

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

Also known as: butorphanol tartrate injection

non-preoperative anxiety and butorphanol; preoperative anxiety and butorphanol

physiological saline OTHER

intravenous infusion of the same volume of physiological saline

non-preoperative anxiety and saline; preoperative anxiety and saline

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ
• years
• Scheduled for elective low limb orthopaedic procedures under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

shengjing hospital of China medical university

Shenyang, Liaoning, 110004, China

Location

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

• Junchao Zhu, professor

  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

Model Details: 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

Study Record Dates

• First Submitted: January 13, 2019
• First Posted: January 18, 2019
• Study Start: December 1, 2017
• Primary Completion: December 20, 2018
• Study Completion: December 31, 2018
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

CN (1)