Muscle RelaxationPhase 4NCT04105764
Deep NMB in Ambulatory Gynecological Laparoscopy
A Phase 4 study testing Rocuronium and Rocuronium bromide in people with Muscle Relaxation, run by Wahba bakhet at 1 site in Kuwait.
Trial summary
Gynecological laparoscopic surgery is commonly performed as an ambulatory basis for the aim of rapid discharge, reduce hospital stay with reduced costs and to improve postoperative QOR [1,2]. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Relaxation
- What is being tested?
- Rocuronium and Rocuronium bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Dec 2016to 15 Jun 2019
- Phase
- Phase 4
- 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 21 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and II
Who cannot join
- Neuromuscular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Neuromuscular Blockade to Improve Postoperative Quality of Recovery in Ambulatory Gynaecologic Laparoscopy
Gynecological laparoscopic surgery is commonly performed as an ambulatory basis for the aim of rapid discharge, reduce hospital stay with reduced costs and to improve postoperative QOR [1,2]. However, the creation of pneumoperitoneum during laparoscopy may cause postoperative pain and other physiological changes [3], which could influence the postoperative QOR negatively [4]. Poor postoperative QOR leads to prolonged hospital stay [5].
Read the detailed description
Deep NMB is known to improve surgical conditions and pneumoperitoneium related complications in laparoscopic surgery [6,7,8,9]. However, it is unknown whether deep NMB improves postoperative QOR in ambulatory gynecological laparoscopy.
Therefore, we designed a double blind randomised trial to compare the effects of deep and moderate NMB on postoperative QOR in ambulatory gynecological laparoscopic surgery. We hypothesized that deep NMB improves postoperative QOR, compared to moderate NMB. The primary outcome was postoperative QOR in POD1. The secondary outcome was quality of surgical conditions, pain scores, time to meet PACU and hospital discharge, and opioid consumption
- Conditions
- Muscle Relaxation
- Being tested
- Rocuronium, Rocuronium bromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Neuromuscular blocker
DEEP block to PTC 1-3
Rocuronium bromideDrug
Also called Neuromuscular blocker
MODERATE block to TOF1-2
| Study group | Role | What they receive |
|---|---|---|
| DEEP BLOCK | Active comparator | In the deep NMB-group, a PTC of 1 to 2 twitches was maintained, and NMB was reversed with sugammadex at the end of surgery. Receives: Drug: Rocuronium |
| Moderate block | Active comparator | In the moderate NMB group, a TOF count of 1 to 2 was maintained and NMB was reversed with a combination of neostigmine and glycopyrolate at the end of surgery. Receives: Drug: Rocuronium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
Quality of recovery-40 (QoR-40) questionnaire, which includes five general quality of life dimensions: physical independence (5 items), pain (7 items), .emotional state (9 items), psychological support (7 items), and physical independence (5 items). Each item was graded with a 5-point score: none of the time, some of the time,usually, most of the time and all of the time. The total score on the QoR- 40 questionnaire ranges from 40 to 200 representing, respectively, extremely poor to excellent
Measured: 24 hours postoperative
Secondary outcomes (1)
Postoperative pain
Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
Measured: During the length of hospital stay post surgery (on average 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Dec 2016
- Primary completion1 Nov 2018
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxationStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wahba bakhet
- Sponsor type
- University, hospital or other
- Collaborators
- Elite medical center
- Responsible party
- Sponsor-investigator, Wahba bakhet, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105764
- Sponsor's protocol ID
- elite NMB
- Status last verified
- Dec 2019
- First submitted
- 25 Sep 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Web
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Neuromuscular Blockade to Improve Postoperative Quality of Recovery in Ambulatory Gynaecologic Laparoscopy
- ClinicalTrials.gov ID
- NCT04105764
- Acronym / sponsor ID
- elite NMB
- Conditions
- Muscle Relaxation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wahba bakhetUniversity, hospital or other
- Collaborators
- Elite medical center
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 26 Sep 2019 (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.
Gynecological laparoscopic surgery is commonly performed as an ambulatory basis for the aim of rapid discharge, reduce hospital stay with reduced costs and to improve postoperative QOR [1,2]. However, the creation of pneumoperitoneum during laparoscopy may cause postoperative pain and other physiological changes [3], which could influence the postoperative QOR negatively [4]. Poor postoperative QOR leads to prolonged hospital stay [5].
Detailed description
Deep NMB is known to improve surgical conditions and pneumoperitoneium related complications in laparoscopic surgery [6,7,8,9]. However, it is unknown whether deep NMB improves postoperative QOR in ambulatory gynecological laparoscopy.
Therefore, we designed a double blind randomised trial to compare the effects of deep and moderate NMB on postoperative QOR in ambulatory gynecological laparoscopic surgery. We hypothesized that deep NMB improves postoperative QOR, compared to moderate NMB. The primary outcome was postoperative QOR in POD1. The secondary outcome was quality of surgical conditions, pain scores, time to meet PACU and hospital discharge, and opioid consumption
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEEP BLOCK | Active comparator | Drug: RocuroniumIn the deep NMB-group, a PTC of 1 to 2 twitches was maintained, and NMB was reversed with sugammadex at the end of surgery. |
| Moderate block | Active comparator | Drug: Rocuronium bromideIn the moderate NMB group, a TOF count of 1 to 2 was maintained and NMB was reversed with a combination of neostigmine and glycopyrolate at the end of surgery. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I and II
Key exclusion criteria (1 listed)
- Neuromuscular disorders
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 |
|---|---|---|
| RocuroniumAlso: Neuromuscular blockerDEEP block to PTC 1-3 | Drug | DEEP BLOCK |
| Rocuronium bromideAlso: Neuromuscular blockerMODERATE block to TOF1-2 | Drug | Moderate block |
Primary outcome
Quality of recovery
Time frame: 24 hours postoperative
Quality of recovery-40 (QoR-40) questionnaire, which includes five general quality of life dimensions: physical independence (5 items), pain (7 items), .emotional state (9 items), psychological support (7 items), and physical independence (5 items). Each item was graded with a 5-point score: none of the time, some of the time,usually, most of the time and all of the time. The total score on the QoR- 40 questionnaire ranges from 40 to 200 representing, respectively, extremely poor to excellent
1 secondary outcome
Postoperative pain
Time frame: During the length of hospital stay post surgery (on average 24 hours)
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 10 Dec 2019.
- Individual participant dataSharing planned: Yes. Web
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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 Phase 4 study testing Rocuronium and Rocuronium bromide in people with Muscle Relaxation, run by Wahba bakhet at 1 site in Kuwait.
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 1 inclusion and 1 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 10 Dec 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 Kuwait. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Quality of recovery (time frame: 24 hours postoperative). 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 10 Dec 2019.