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NCT Number: NCT03429179

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

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.

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Key information

Conditions

Preoperative Anxiety Precise 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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Physiological Saline

Other

intravenous infusion of the same volume of 0.9% saline

Primary outcomes

  1. preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS)".

    Time frame: before the surgery

    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

  2. Ramsay Sedation score

    Time frame: during the surgery

    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

  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 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

  4. vital signs

    Time frame: during the surgery

    Record Mean Arterial Pressure(MAP)10min after getting into the operation room and 5,10,15,30min after infusion

Secondary outcomes

  1. vital signs

    Time frame: during the surgery

    Record SPO2 10min after getting into the operation room and 5,10,15,30min after infusion

  2. Vital signs

    Time frame: during the surgery

    Record Heart Rate(HR) 10min after getting into the operation room and 5,10,15,30min after infusion

  3. The incidence of nausea/vomiting dizzy bradycardia and hypotension

    Time frame: first day after the surgery

    investigate the incidence of nausea/vomiting dizzy bradycardia and hypotension in the first day after the surgery

  4. post operative visual analgesia scale scores (VAS)

    Time frame: within 24 hours after the surgery

    assess the visual analgesia scale scores (VAS) every hour till 6 h and then every 2 h till 24 h

  5. postoperative patient satisfaction

    Time frame: first day after the surgery

    Patient satisfaction was recorded on 5 levels: a) agreeable experience; b) neither pleasant nor unpleasant; c) slightly uncomfortable; d) disagreeable; e) a traumatic experience.

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

Using Pre-operative Anxiety Score to Determine the Precise Dose of Butorphanol in Patients Undergoing Orthopedic Procedures: A Double-blinded Randomized Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2018
Registry last updated
May 15, 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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