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Preoperative Anxiety ScorePhase 2NCT03810391

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

A Phase 2 study testing Butorphanol and physiological saline in people with Preoperative Anxiety Score and Total 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

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. 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
126 participants
Where
1 siteChina
Study dates
1 Dec 2017to 31 Dec 2018
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

  • American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ
  • 18-75 years
  • Scheduled for elective low limb orthopaedic procedures under spinal anesthesia

Who cannot join

  • 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

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 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

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

Read the 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.

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

    Also called butorphanol tartrate injection

    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

  • physiological salineOther

    intravenous infusion of the same volume of physiological saline

Study groups in NCT03810391
Study groupRoleWhat they receive
preoperative anxiety and butorphanolExperimentalpreoperative 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
Receives: Drug: Butorphanol
preoperative anxiety and salinePlacebo comparatorpreoperative anxiety scores of patients in Group B were >11 and received an infusion of the same volume of physiological saline
Receives: Other: physiological saline
non-preoperative anxiety and butorphanolExperimentalpreoperative 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
Receives: Drug: Butorphanol
non-preoperative anxiety and salinePlacebo comparatorpreoperative anxiety scores of patients in Group D were ≤11 and received an infusion of the same volume of physiological 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 (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

    Measured: one day before the surgery

  2. 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

    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 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

    Measured: Ramsay sedation score reach 4 points during the surgery

Secondary outcomes (5)

  1. vital signs

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

    Measured: during the surgery

  2. 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: in the first day after the surgery

  3. post-operative visual analgesia scale scores (VAS)

    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

    Measured: within 24 hours after the surgery

  4. Vital signs

    Record Spo2 10 min after getting into the operation room and 5, 10, 15, 30min after infusion

    Measured: during the surgery

  5. Vital signs

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

    Measured: during 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 posted18 Jan 2019
  2. Study start1 Dec 2017
  3. Primary completion20 Dec 2018
  4. Study completion31 Dec 2018

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
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03810391
Sponsor's protocol ID
Effect of butorphanol
Status last verified
Jan 2019
First submitted
13 Jan 2019
Last updated
18 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Butorphanol and physiological saline in people with Preoperative Anxiety Score and Total 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 3 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 18 Jan 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 (Amsterdam preoperative anxiety and information scale, APAIS) (time frame: one day before the surgery). The study lists 3 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 NCT03810391.

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 18 Jan 2019.

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