Laparoscopic CholecystectomyPhase 2NCT02469831
Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy
A Phase 2 study testing Rocuronium in people with Laparoscopic Cholecystectomy, run by Assiut University at 1 site in Egypt.
Trial summary
The investigators aim to investigate the differences between deep continuous muscle relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in respect to metabolic changes and respiratory mechanics. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2014to Jan 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- more than 18 years
- undergoing elective laparoscopic cholecystectomy
Who cannot join
- previous surgeries,
- a history of venous or arterial diseases,
- BMI (≥30 kg/m2),
- Allergy to rocuronium.
- Significant liver dysfunction.
- Significant renal dysfunction (S-creatinine > 200 umol/l).
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- Neuromuscular disease that might impair neuromuscular blockade
- Pregnant or breastfeeding.
- Indication for rapid sequence induction.
- Inability to informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Deep Versus Moderate Neuromuscular Block on Respiratory System Mechanics and Metabolic Changes During Laparoscopic Cholecystectomy a Double-Blind Randomized Clinical Trial.
The investigators aim to investigate the differences between deep continuous muscle relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in respect to metabolic changes and respiratory mechanics.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
| Study group | Role | What they receive |
|---|---|---|
| group D | Active comparator | deep neuromuscular block by rocuronium defined :post tetanic (PTC) >1 but no response to a train of four (TOF) stimulation. Receives: Drug: Rocuronium |
| group I | Active comparator | intermediate neuromuscular block by rocuronium defined as TOF count of 1-3. Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory mechanics (Dynamic compliance)
Dynamic compliance
Measured: intraoperative
Secondary outcomes (5)
surgeon satisfaction (scale from 1 to 5)
scale from 1 to 5
Measured: intraoperative
postoperative pain (VAS score)
VAS score
Measured: postoperative for 6 hours
postoperative nausea and vomiting
Measured: postoperative for 6 hours
completion of surgical procedure
yes or no
Measured: intraoperative
metabolic changes (blood lactate)
blood lactate
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled salah mohamed, Assiut University
- Investigators
- Osama ibraheim, MD, Study chair, Assiut UniversityMOSTAFA ABBAS, MD, Study chair, Assiut UniversityAHMED TAHA, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469831
- Sponsor's protocol ID
- low pressure lap chole.
- Status last verified
- Mar 2017
- First submitted
- 24 May 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Deep Versus Moderate Neuromuscular Block on Respiratory System Mechanics and Metabolic Changes During Laparoscopic Cholecystectomy a Double-Blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02469831
- Acronym / sponsor ID
- low pressure lap chole.
- Conditions
- Laparoscopic Cholecystectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Jun 2015 (estimated)
- 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.
The investigators aim to investigate the differences between deep continuous muscle relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in respect to metabolic changes and respiratory mechanics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group D | Active comparator | Drug: Rocuroniumdeep neuromuscular block by rocuronium defined :post tetanic (PTC) >1 but no response to a train of four (TOF) stimulation. |
| group I | Active comparator | Drug: Rocuroniumintermediate neuromuscular block by rocuronium defined as TOF count of 1-3. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- more than 18 years
- undergoing elective laparoscopic cholecystectomy
Key exclusion criteria (10 listed)
- previous surgeries,
- a history of venous or arterial diseases,
- BMI (≥30 kg/m2),
- Allergy to rocuronium.
- Significant liver dysfunction.
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 |
|---|---|---|
| Rocuronium | Drug | group D, group I |
Primary outcome
respiratory mechanics (Dynamic compliance)
Time frame: intraoperative
Dynamic compliance
5 secondary outcomes
surgeon satisfaction (scale from 1 to 5)
Time frame: intraoperative
postoperative pain (VAS score)
Time frame: postoperative for 6 hours
postoperative nausea and vomiting
Time frame: postoperative for 6 hours
completion of surgical procedure
Time frame: intraoperative
metabolic changes (blood lactate)
Time frame: intraoperative
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 28 Mar 2017.
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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.
Osama ibraheim, MD study chair
Assiut University
MOSTAFA ABBAS, MD study chair
Assiut University
AHMED TAHA, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rocuronium in people with Laparoscopic Cholecystectomy, run by Assiut University at 1 site in Egypt.
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 10 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 28 Mar 2017. 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 Egypt. 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 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?
respiratory mechanics (Dynamic compliance) (time frame: intraoperative). 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 28 Mar 2017.