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NCT Number: NCT03810391

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

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

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Key information

Conditions

Preoperative Anxiety Score Total Dose of Butorphanol

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

shengjing hospital of China medical university

Shenyang, Liaoning, 110004, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: butorphanol tartrate injection

Physiological Saline

Other

intravenous infusion of the same volume of physiological saline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2019
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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