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

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ClinicalTrials.gov Identifier: NCT03810391
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Yanchao Yang, Shengjing Hospital

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

Condition or disease Intervention/treatment Phase
Preoperative Anxiety Score Total Dose of Butorphanol Drug: Butorphanol Other: physiological saline Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: preoperative anxiety and butorphanol
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
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 Name: butorphanol tartrate injection

Placebo Comparator: preoperative anxiety and saline
preoperative anxiety scores of patients in Group B were >11 and received an infusion of the same volume of physiological saline
Other: physiological saline
intravenous infusion of the same volume of physiological saline

Experimental: non-preoperative anxiety and butorphanol
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
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 Name: butorphanol tartrate injection

Placebo Comparator: non-preoperative anxiety and saline
preoperative anxiety scores of patients in Group D were ≤11 and received an infusion of the same volume of physiological saline
Other: physiological saline
intravenous infusion of the same volume of physiological saline




Primary Outcome Measures :
  1. preoperative anxiety score (Amsterdam preoperative anxiety and information scale, APAIS) [ Time Frame: one day before the surgery ]
    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

  2. Ramsay sedation score (Ramsay sedation scale, RSS) [ Time Frame: during the surgery ]
    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

  3. the time when Ramsay sedation score reached 4 points [ Time Frame: Ramsay sedation score reach 4 points during the surgery ]
    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


Secondary Outcome Measures :
  1. vital signs [ Time Frame: during the surgery ]
    Record Mean Arterial Pressure(MAP)10 min after getting into the operation room and 5, 10, 15, 30min after infusion

  2. The incidence of nausea/ vomiting, dizzy, bradycardia and hypotension [ Time Frame: in the first day after the surgery ]
    Investigate the incidence of nausea/ vomiting, dizzy, bradycardia and hypotension in the first day after the surgery

  3. post-operative visual analgesia scale scores (VAS) [ Time Frame: within 24 hours after the surgery ]
    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

  4. Vital signs [ Time Frame: during the surgery ]
    Record Spo2 10 min after getting into the operation room and 5, 10, 15, 30min after infusion

  5. Vital signs [ Time Frame: during the surgery ]
    Record Heart Rate(HR) 10 min after getting into the operation room and 5, 10, 15, 30min after infusion



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810391


Locations
China, Liao Ning
shengjing hospital of China medical university
Shenyang, Liao Ning, China, 110004
Sponsors and Collaborators
Shengjing Hospital
Investigators
Study Director: Junchao Zhu, professor Shengjing Hospital

Responsible Party: Yanchao Yang, Principal Investigator, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03810391     History of Changes
Other Study ID Numbers: Effect of butorphanol
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yanchao Yang, Shengjing Hospital:
Butorphanol
preoperative anxiety
sedation
recommend dose

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Butorphanol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Narcotic Antagonists