Neuromuscular BlockadeNCT06469866
Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy
A study testing low-pressure pneumoperitoneum and standard-pressure pneumoperitoneum in people with Neuromuscular Blockade and Laparoscopy, run by Anqing Municipal Hospital at 1 site in China.
Trial summary
BACKGROUND: Some studies have revealed that deep neuromuscular block (NMB) improve surgical conditions and alleviated postoperative pain compared with moderate NMB. The present study investigated deep NMB could improve the quality of recovery after laparoscopic hysterectomy METHODS: seventy-two women with elective… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Neuromuscular Blockade, Laparoscopy
- What is being tested?
- low-pressure pneumoperitoneum and standard-pressure pneumoperitoneum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2024to 25 Nov 2024
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅲ
- Scheduled for elective laparoscopic hysterectomy
Who cannot join
- Inability to give informed consent
- BMI >35
- Renal or hepatic insufficiency
- History of preoperative psychiatric
- Previous surgery at procedure site
- Neuromuscular disease, pregnancy, and contraindications to study medications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anqing Munucipal Hospital Anesthesiology
Anqing, Anhui, 246000
xu siqi, errtg555@163.com
13865192106
About this study
Official title: Effect of Deep Neuromuscular Block on the Quality of Recovery After Laparoscopic Hysterectomy
BACKGROUND: Some studies have revealed that deep neuromuscular block (NMB) improve surgical conditions and alleviated postoperative pain compared with moderate NMB. The present study investigated deep NMB could improve the quality of recovery after laparoscopic hysterectomy
METHODS: seventy-two women with elective laparoscopic hysterectomy were randomly divided into 2 groups: Patients in group A received low-pressure pneumoperitoneum (LPP), which was set at 8-10 mmHg with deep NMB. Patients in group B received standard-pressure pneumoperitoneum (SPP), which was set at 12-14 mmHg with moderate NMB. Primary outcome was the quality of recovery (QoR-15) at 1 day after sugery. The secondary outcomes included postoperative pain, surgical condition, incidence of shoulder pain, the incidence of rescue analgesic drug use, cumulative dose of analgesics, time of first flatus, post-operative nausea and vomiting, time of tracheal tube removal.
- Conditions
- Neuromuscular Blockade, Laparoscopy
- Being tested
- low-pressure pneumoperitoneum, standard-pressure pneumoperitoneum
- Keywords
- Neuromuscular block, Recovery, Laparoscopic hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-pressure pneumoperitoneumDevice
low-pressure pneumoperitoneum (LPP) with deep NMB.
standard-pressure pneumoperitoneumDevice
standard-pressure pneumoperitoneum (SPP) with moderate NMB.
| Study group | Role | What they receive |
|---|---|---|
| low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery | Experimental | low-pressure pneumoperitoneum (LPP) with deep NMB. Receives: Device: low-pressure pneumoperitoneum; Device: standard-pressure pneumoperitoneum |
| standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery | Experimental | standard-pressure pneumoperitoneum (SPP) with moderate NMB. Receives: Device: low-pressure pneumoperitoneum; Device: standard-pressure pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
Primary outcome measure was the quality of recovery at 1 day after surgery. Quality of recovery-15 scale was used to assess the quality of recovery after operation. A higher score of quality of recovery-15 scale indicates a better quality of recovery after surgery
Measured: 1 day after operation
Secondary outcomes (2)
Shoulder pain
Secondary Outcome Measure was the incidence of shoulder pain
Measured: The first 24 hours after operation
Postoperative nausea and vomiting
Secondary Outcome Measure was the incidence of postoperative nausea and vomiting. PONV score was evaluated verbally with a descriptive scale (0 = None, 1 = Mild Nausea, 2 = Moderate Nausea, 3 = One Vomiting, 4 = Multiple Vomiting).
Measured: The first 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start25 Jun 2024 (estimated)
- Primary completion25 Nov 2024 (estimated)
- Study completion25 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anqing Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469866
- Sponsor's protocol ID
- xuzhang520
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 24 Jun 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Neuromuscular Block on the Quality of Recovery After Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT06469866
- Acronym / sponsor ID
- xuzhang520
- Conditions
- Neuromuscular Blockade, Laparoscopy
- Keywords
- Neuromuscular block, Recovery, Laparoscopic hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Anqing Municipal HospitalUniversity, hospital or other
- Study start
- 25 Jun 2024 (estimated)
- Primary completion
- 25 Nov 2024 (estimated)
- Study completion
- 25 Nov 2024 (estimated)
- First posted
- 24 Jun 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.
BACKGROUND: Some studies have revealed that deep neuromuscular block (NMB) improve surgical conditions and alleviated postoperative pain compared with moderate NMB. The present study investigated deep NMB could improve the quality of recovery after laparoscopic hysterectomy
METHODS: seventy-two women with elective laparoscopic hysterectomy were randomly divided into 2 groups: Patients in group A received low-pressure pneumoperitoneum (LPP), which was set at 8-10 mmHg with deep NMB. Patients in group B received standard-pressure pneumoperitoneum (SPP), which was set at 12-14 mmHg with moderate NMB. Primary outcome was the quality of recovery (QoR-15) at 1 day after sugery. The secondary outcomes included postoperative pain, surgical condition, incidence of shoulder pain, the incidence of rescue analgesic drug use, cumulative dose of analgesics, time of first flatus, post-operative nausea and vomiting, time of tracheal tube removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery | Experimental | Device: low-pressure pneumoperitoneum, Device: standard-pressure pneumoperitoneumlow-pressure pneumoperitoneum (LPP) with deep NMB. |
| standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery | Experimental | Device: low-pressure pneumoperitoneum, Device: standard-pressure pneumoperitoneumstandard-pressure pneumoperitoneum (SPP) with moderate NMB. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅲ
- Scheduled for elective laparoscopic hysterectomy
Key exclusion criteria (6 listed)
- Inability to give informed consent
- BMI >35
- Renal or hepatic insufficiency
- History of preoperative psychiatric
- Previous surgery at procedure site
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 |
|---|---|---|
| low-pressure pneumoperitoneumlow-pressure pneumoperitoneum (LPP) with deep NMB. | Device | low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery, standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery |
| standard-pressure pneumoperitoneumstandard-pressure pneumoperitoneum (SPP) with moderate NMB. | Device | low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery, standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery |
Primary outcome
Quality of recovery
Time frame: 1 day after operation
Primary outcome measure was the quality of recovery at 1 day after surgery. Quality of recovery-15 scale was used to assess the quality of recovery after operation. A higher score of quality of recovery-15 scale indicates a better quality of recovery after surgery
2 secondary outcomes
Shoulder pain
Time frame: The first 24 hours after operation
Postoperative nausea and vomiting
Time frame: The first 24 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-pressure pneumoperitoneum and standard-pressure pneumoperitoneum in people with Neuromuscular Blockade and Laparoscopy, run by Anqing Municipal 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 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: status not confirmed, as of the sponsor's last update on 24 Jun 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu si qi, Doctor (13865192106, errtg555@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery (time frame: 1 day after operation). 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 24 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.