ButorphanolNCT06524596
Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia
A study testing tartaric acid butorphanol, normal saline and propofol and remifentanil in people with Butorphanol, run by Wuhan Children's Hospital at 1 site in China.
Trial summary
To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. Read more about this study
- Who is it for?
- Ages 33 to 50 years, women only
- Conditions the study is for
- Butorphanol
- What is being tested?
- tartaric acid butorphanol, normal saline and propofol and remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 May 2023
- Phase
- Interventional
- 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 33 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women patients, aged 18-65 years, with an American Society of Anesthesiologists physical status of I or II
- undergoing elective gynaecological laparoscopy for benign diseases
Who cannot join
- patients who had an allergy or contraindication to any study drug
- had chronic pain or opioid use
- had a history of substance abuse or psychiatric disorders
- were pregnant or lactating
- had a severe cardiovascular, respiratory, renal, hepatic or haematological disease
- had a body mass index >30 kg/m2
- had an inability to understand or cooperate with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wuhan Children's Hospital
To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30) and the control group (n = 29). Both groups received TIVA with propofol and remifentanil. Observing two groups of patients on the visual analog scale, the total consumption of rescue analogies, and the confidence of postoperative nausea and vomiting (PONV), and the patient satisfaction score.
Read the detailed description
To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30), who received 0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction, and the control group (n = 29), who received the same volume of normal saline. Both groups received TIVA with propofol and remifentanil. The primary outcome was the visual analogue scale (VAS) score for pain at rest and on movement at 1, 2, 4, 6, 12 and 24 hours after surgery. The secondary outcomes were the total consumption of rescue analgesics, the incidence and severity of postoperative nausea and vomiting (PONV), and the patient satisfaction score.
- Conditions
- Butorphanol
- Being tested
- tartaric acid butorphanol, normal saline, propofol and remifentanil
- Keywords
- Analgesia, Remifentanil, Postoperative Pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tartaric acid butorphanolDrug
The group received 0.02 mg/kg tartaric acid butorphanol intravenously over 5 minutes, 30 minutes before anaesthesia induction
normal salineDrug
The group received 0.02 mg/kg normal saline intravenously over 5 minutes, 30 minutes before anaesthesia induction
propofol and remifentanilDrug
Anaesthesia was induced with 2 mg/kg propofol and 0.6 μg/kg remifentanil and maintained with a target-controlled infusion (TCI) of propofol and remifentanil, using the Marsh and Minto models, respectively.
| Study group | Role | What they receive |
|---|---|---|
| the butorphanol group | Experimental | 0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction. Receives: Drug: tartaric acid butorphanol; Drug: propofol and remifentanil |
| the control group | Placebo comparator | 0.02 mg/kg of normal saline intravenously 30 minutes prior to anaesthesia induction. Receives: Drug: normal saline; Drug: propofol and remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale ( VAS ) scores for pain
Pain was assessed at 1 hour to evaluate immediate postoperative pain while allowing time to recover from anaesthesia.
Measured: at 1 hour after surgery
Visual analogue scale ( VAS ) scores for pain
Pain was assessed at 2 hours after surgery.
Measured: at 2 hours after surgery
Visual analogue scale ( VAS ) scores for pain
Pain was assessed at 4 hours after surgery.
Measured: at 4 hours after surgery
Visual analogue scale ( VAS ) scores for pain
Pain was assessed at 6 hours after surgery.
Measured: at 6 hours after surgery
Visual analogue scale ( VAS ) scores for pain
Pain was assessed at 12 hours after surgery.
Measured: at 12 hours after surgery
Visual analogue scale ( VAS ) scores for pain
Pain was assessed at 24 hours after surgery.
Measured: at 24 hours after surgery
Secondary outcomes (4)
the total rescue analgesic consumption (mg)
The total rescue analgesic consumption was calculated by adding the amount of morphine delivered by PCA and any supplemental tramadol given by the nurse for inadequate pain control (VAS >4) or at the patient's request, ensuring that the total opioid dose was within safe limits.
Measured: within 24 hours after surgery
the incidence of postoperative nausea and vomiting(PONV)
The incidence of postoperative nausea and vomiting(PONV) was defined as any nausea, vomiting or both
Measured: within 24 hours after surgery
the nausea severity of postoperative nausea and vomiting(PONV)
The nausea severity was rated on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe)
Measured: within 24 hours after surgery
patient satisfaction score
Patient satisfaction was assessed using a 5-point scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied).
Measured: at 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ButorphanolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Wang, Wuhan Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524596
- Sponsor's protocol ID
- WHCH-008
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wuhan Children's Hospital
- ClinicalTrials.gov ID
- NCT06524596
- Acronym / sponsor ID
- WHCH-008
- Conditions
- Butorphanol
- Keywords
- Analgesia, Remifentanil, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Wuhan Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30) and the control group (n = 29). Both groups received TIVA with propofol and remifentanil. Observing two groups of patients on the visual analog scale, the total consumption of rescue analogies, and the confidence of postoperative nausea and vomiting (PONV), and the patient satisfaction score.
Detailed description
To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30), who received 0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction, and the control group (n = 29), who received the same volume of normal saline. Both groups received TIVA with propofol and remifentanil. The primary outcome was the visual analogue scale (VAS) score for pain at rest and on movement at 1, 2, 4, 6, 12 and 24 hours after surgery. The secondary outcomes were the total consumption of rescue analgesics, the incidence and severity of postoperative nausea and vomiting (PONV), and the patient satisfaction score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the butorphanol group | Experimental | Drug: tartaric acid butorphanol, Drug: propofol and remifentanil0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction. |
| the control group | Placebo comparator | Drug: normal saline, Drug: propofol and remifentanil0.02 mg/kg of normal saline intravenously 30 minutes prior to anaesthesia induction. |
Who may qualify
- Ages
- 33 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women patients, aged 18-65 years, with an American Society of Anesthesiologists physical status of I or II
- undergoing elective gynaecological laparoscopy for benign diseases
Key exclusion criteria (7 listed)
- patients who had an allergy or contraindication to any study drug
- had chronic pain or opioid use
- had a history of substance abuse or psychiatric disorders
- were pregnant or lactating
- had a severe cardiovascular, respiratory, renal, hepatic or haematological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tartaric acid butorphanolThe group received 0.02 mg/kg tartaric acid butorphanol intravenously over 5 minutes, 30 minutes before anaesthesia induction | Drug | the butorphanol group |
| normal salineThe group received 0.02 mg/kg normal saline intravenously over 5 minutes, 30 minutes before anaesthesia induction | Drug | the control group |
| propofol and remifentanilAnaesthesia was induced with 2 mg/kg propofol and 0.6 μg/kg remifentanil and maintained with a target-controlled infusion (TCI) of propofol and remifentanil, using the Marsh and Minto models, respectively. | Drug | the butorphanol group, the control group |
Primary outcome
Visual analogue scale ( VAS ) scores for pain
Time frame: at 1 hour after surgery
Pain was assessed at 1 hour to evaluate immediate postoperative pain while allowing time to recover from anaesthesia.
Visual analogue scale ( VAS ) scores for pain
Time frame: at 2 hours after surgery
Pain was assessed at 2 hours after surgery.
Visual analogue scale ( VAS ) scores for pain
Time frame: at 4 hours after surgery
Pain was assessed at 4 hours after surgery.
Visual analogue scale ( VAS ) scores for pain
Time frame: at 6 hours after surgery
Pain was assessed at 6 hours after surgery.
Visual analogue scale ( VAS ) scores for pain
Time frame: at 12 hours after surgery
Pain was assessed at 12 hours after surgery.
Visual analogue scale ( VAS ) scores for pain
Time frame: at 24 hours after surgery
Pain was assessed at 24 hours after surgery.
4 secondary outcomes
the total rescue analgesic consumption (mg)
Time frame: within 24 hours after surgery
the incidence of postoperative nausea and vomiting(PONV)
Time frame: within 24 hours after surgery
the nausea severity of postoperative nausea and vomiting(PONV)
Time frame: within 24 hours after surgery
patient satisfaction score
Time frame: at 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tartaric acid butorphanol, normal saline and propofol and remifentanil in people with Butorphanol, run by Wuhan Children's 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 2 inclusion and 7 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 29 Jul 2024. 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.
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?
Visual analogue scale ( VAS ) scores for pain (time frame: at 1 hour after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2024.