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Preoperative AnxietyPhase 2NCT03429179

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

A Phase 2 study testing Butorphanol and Physiological saline in people with Preoperative Anxiety and Precise Dose of Butorphanol, run by Shengjing Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Butorphanol and Physiological saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
155 participants
Where
1 siteChina
Study dates
5 Mar 2018to 5 Mar 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • shengjing hospital of China medical university

    Shenyang, Liaoning, 110004

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
Butorphanol, Physiological saline
Keywords
butorphanol, preoperative anxiety, sedation, recommend dose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ButorphanolDrug

    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 salineOther

    intravenous infusion of the same volume of 0.9% saline

Study groups in NCT03429179
Study groupRoleWhat they receive
High anxiety butorphanol groupExperimentalpreoperative 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
Receives: Drug: Butorphanol
High anxiety 0.9% saline groupPlacebo comparatorpreoperative 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
Receives: Other: Physiological saline
Low anxiety butorphanol groupExperimentalpreoperative 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
Receives: Drug: Butorphanol
Low anxiety 0.9% saline groupPlacebo comparatorpreoperative 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
Receives: Other: Physiological saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: before the surgery

  2. 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

    Measured: during the surgery

  3. 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

    Measured: Ramsay sedation score reach 4 points during the surgery

  4. vital signs

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

    Measured: during the surgery

Secondary outcomes (5)

  1. vital signs

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

    Measured: during the surgery

  2. Vital signs

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

    Measured: during the surgery

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

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

    Measured: first day after the surgery

  4. post operative visual analgesia scale scores (VAS)

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

    Measured: within 24 hours after the surgery

  5. postoperative patient satisfaction

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

    Measured: first day after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2018
  2. Study start5 Mar 2018
  3. Primary completion20 Feb 2019
  4. Study completion5 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03429179
Sponsor's protocol ID
the effect of butorphanol
Status last verified
Mar 2019
First submitted
20 Jan 2018
Last updated
15 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31611935

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Butorphanol and Physiological saline in people with Preoperative Anxiety and Precise Dose of Butorphanol, run by Shengjing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS)". (time frame: before the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03429179, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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