AnesthesiaPhase 3NCT00970762
Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)
A Phase 3 study testing Rocuronium 0.6 mg/kg intubating dose, Rocuronium 0.9 mg/kg intubating dose and Rocuronium 0.1 mg/kg maintenance dose in people with Anesthesia, run by Merck Sharp & Dohme LLC.
Trial summary
This study was conducted to determine and compare the safety and effectiveness of two neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are undergoing general elective surgery with sevoflurane anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Rocuronium 0.6 mg/kg intubating dose, Rocuronium 0.9 mg/kg intubating dose and Rocuronium 0.1 mg/kg maintenance dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Feb 2004
- Phase
- Phase 3
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 20 but under 65 years of age
- American Society of Anesthesiologists (ASA) Class 1, 2 or 3 for general elective surgery
- not considered to be pregnant
- scheduled for elective surgery under sevoflurane or propofol anesthesia with an anticipated duration of about 1.5-3 hours
- normal laboratory values
Who cannot join
- certain medical conditions or medical histories
- receiving certain medications or treatments
About this study
Official title: Comparative Study of Org 9426 With Vecuronium Bromide (Phase III)
This study was conducted to determine and compare the safety and effectiveness of two neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are undergoing general elective surgery with sevoflurane anesthesia.
Study participants received an intubating dose of a neuromuscular blocker (to enable insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed, to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular blocker (onset time) after the intubating dose was measured and compared as the primary outcome.
Read the detailed description
The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular blocking action.
- Conditions
- Anesthesia
- Being tested
- Rocuronium 0.6 mg/kg intubating dose, Rocuronium 0.9 mg/kg intubating dose, Rocuronium 0.1 mg/kg maintenance dose, Rocuronium 0.15 mg/kg maintenance dose, Rocuronium 0.2 mg/kg maintenance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium 0.6 mg/kg intubating doseDrug
Also called Zemuron, Org 9426
Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.9 mg/kg intubating doseDrug
Also called Zemuron, Org 9426
0.9 mg/kg intubating dose of rocuronium
Rocuronium 0.1 mg/kg maintenance doseDrug
Also called Zemuron, Org 9426
Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.
Rocuronium 0.15 mg/kg maintenance doseDrug
Also called Zemuron, Org 9426
Rocuronium 0.15 mg/kg maintenance dose following the intubating dose
Rocuronium 0.2 mg/kg maintenanceDrug
Also called Zemuron, Org 9426
Rocuronium 0.2 mg/kg maintenance dose following the intubating dose
Vecuronium 0.1 mg/kg intubating doseDrug
Also called Norcuron
Vecuronium 0.1 mg/kg intubating dose
Vecuronium 0.025 mg/kg maintenance doseDrug
Also called Norcuron
Vecuronium 0.025 mg/kg maintenance dose following the intubating dose
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium 0.6 INT, 0.1 MNT | Experimental | Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium. Receives: Drug: Rocuronium 0.6 mg/kg intubating dose; Drug: Rocuronium 0.1 mg/kg maintenance dose |
| Rocuronium 0.6 INT, 0.15 MNT | Experimental | Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium. Receives: Drug: Rocuronium 0.6 mg/kg intubating dose; Drug: Rocuronium 0.15 mg/kg maintenance dose |
| Rocuronium 0.6 INT, 0.2 MNT | Experimental | Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium. Receives: Drug: Rocuronium 0.6 mg/kg intubating dose; Drug: Rocuronium 0.2 mg/kg maintenance |
| Rocuronium 0.9 INT, 0.1 MNT | Experimental | Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium. Receives: Drug: Rocuronium 0.9 mg/kg intubating dose; Drug: Rocuronium 0.1 mg/kg maintenance dose |
| Rocuronium 0.9 INT, 0.15 MNT | Experimental | Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium. Receives: Drug: Rocuronium 0.9 mg/kg intubating dose; Drug: Rocuronium 0.15 mg/kg maintenance dose |
| Rocuronium 0.9 INT, 0.2 MNT | Experimental | Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium. Receives: Drug: Rocuronium 0.9 mg/kg intubating dose; Drug: Rocuronium 0.2 mg/kg maintenance |
| Vecuronium 0.1 INT, 0.025 MNT | Active comparator | Participants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium. Receives: Drug: Vecuronium 0.1 mg/kg intubating dose; Drug: Vecuronium 0.025 mg/kg maintenance dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of intubating dose. DESCRIPTION: The time interval between the completion of injection of the study drug (rocuronium or vecuronium) and the maximal depression of first twitch--measured via TOF Watch Sx(R)-- was defined as the onset time.
Measured: Day of Surgery, after injection of study drug until maximal depression of first twitch achieved
Secondary outcomes (2)
Number of subjects who achieved maximal block >=90% after the intubating dose. DESCRIPTION: Reaching a 90% depression of first twitch--measured via TOF Watch Sx(R)--was defined as achieving 90% block
Measured: Day of Surgery, after injection of study drug until maximal depression of first twice achieved
Clinical duration after first maintenance dose. DESCRIPTION: The time interval between the completion of injection of study drug and return of first twitch to 25%(as measured by TOF Watch Sx(R)) was defined as the clinical duration.
Measured: Day of Surgery, after injection of study drug until return of first twitch to 25%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startFeb 2003
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970762
- Sponsor's protocol ID
- P05975
- Other IDs
- 71101
- Status last verified
- Apr 2015
- First submitted
- 23 Jul 2009
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Org 9426 With Vecuronium Bromide (Phase III)
- ClinicalTrials.gov ID
- NCT00970762
- Acronym / sponsor ID
- P05975
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 2 Sep 2009 (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.
This study was conducted to determine and compare the safety and effectiveness of two neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are undergoing general elective surgery with sevoflurane anesthesia.
Study participants received an intubating dose of a neuromuscular blocker (to enable insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed, to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular blocker (onset time) after the intubating dose was measured and compared as the primary outcome.
Detailed description
The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular blocking action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Rocuronium 0.6 INT, 0.1 MNT | Experimental | Drug: Rocuronium 0.6 mg/kg intubating dose, Drug: Rocuronium 0.1 mg/kg maintenance doseParticipants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium. |
| Rocuronium 0.6 INT, 0.15 MNT | Experimental | Drug: Rocuronium 0.6 mg/kg intubating dose, Drug: Rocuronium 0.15 mg/kg maintenance doseParticipants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium. |
| Rocuronium 0.6 INT, 0.2 MNT | Experimental | Drug: Rocuronium 0.6 mg/kg intubating dose, Drug: Rocuronium 0.2 mg/kg maintenanceParticipants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium. |
| Rocuronium 0.9 INT, 0.1 MNT | Experimental | Drug: Rocuronium 0.9 mg/kg intubating dose, Drug: Rocuronium 0.1 mg/kg maintenance doseParticipants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium. |
| Rocuronium 0.9 INT, 0.15 MNT | Experimental | Drug: Rocuronium 0.9 mg/kg intubating dose, Drug: Rocuronium 0.15 mg/kg maintenance doseParticipants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium. |
| Rocuronium 0.9 INT, 0.2 MNT | Experimental | Drug: Rocuronium 0.9 mg/kg intubating dose, Drug: Rocuronium 0.2 mg/kg maintenanceParticipants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium. |
| Vecuronium 0.1 INT, 0.025 MNT | Active comparator | Drug: Vecuronium 0.1 mg/kg intubating dose, Drug: Vecuronium 0.025 mg/kg maintenance doseParticipants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 20 but under 65 years of age
- American Society of Anesthesiologists (ASA) Class 1, 2 or 3 for general elective surgery
- not considered to be pregnant
- scheduled for elective surgery under sevoflurane or propofol anesthesia with an anticipated duration of about 1.5-3 hours
- normal laboratory values
Key exclusion criteria (2 listed)
- certain medical conditions or medical histories
- receiving certain medications or treatments
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 0.6 mg/kg intubating doseAlso: Zemuron, Org 9426Rocuronium 0.6 mg/kg intubating dose | Drug | Rocuronium 0.6 INT, 0.1 MNT, Rocuronium 0.6 INT, 0.15 MNT, Rocuronium 0.6 INT, 0.2 MNT |
| Rocuronium 0.9 mg/kg intubating doseAlso: Zemuron, Org 94260.9 mg/kg intubating dose of rocuronium | Drug | Rocuronium 0.9 INT, 0.1 MNT, Rocuronium 0.9 INT, 0.15 MNT, Rocuronium 0.9 INT, 0.2 MNT |
| Rocuronium 0.1 mg/kg maintenance doseAlso: Zemuron, Org 9426Rocuronium 0.1 mg/kg maintenance dose following the intubating dose. | Drug | Rocuronium 0.6 INT, 0.1 MNT, Rocuronium 0.9 INT, 0.1 MNT |
| Rocuronium 0.15 mg/kg maintenance doseAlso: Zemuron, Org 9426Rocuronium 0.15 mg/kg maintenance dose following the intubating dose | Drug | Rocuronium 0.6 INT, 0.15 MNT, Rocuronium 0.9 INT, 0.15 MNT |
| Rocuronium 0.2 mg/kg maintenanceAlso: Zemuron, Org 9426Rocuronium 0.2 mg/kg maintenance dose following the intubating dose | Drug | Rocuronium 0.6 INT, 0.2 MNT, Rocuronium 0.9 INT, 0.2 MNT |
| Vecuronium 0.1 mg/kg intubating doseAlso: NorcuronVecuronium 0.1 mg/kg intubating dose | Drug | Vecuronium 0.1 INT, 0.025 MNT |
| Vecuronium 0.025 mg/kg maintenance doseAlso: NorcuronVecuronium 0.025 mg/kg maintenance dose following the intubating dose | Drug | Vecuronium 0.1 INT, 0.025 MNT |
Primary outcome
Onset time of intubating dose. DESCRIPTION: The time interval between the completion of injection of the study drug (rocuronium or vecuronium) and the maximal depression of first twitch--measured via TOF Watch Sx(R)-- was defined as the onset time.
Time frame: Day of Surgery, after injection of study drug until maximal depression of first twitch achieved
2 secondary outcomes
Number of subjects who achieved maximal block >=90% after the intubating dose. DESCRIPTION: Reaching a 90% depression of first twitch--measured via TOF Watch Sx(R)--was defined as achieving 90% block
Time frame: Day of Surgery, after injection of study drug until maximal depression of first twice achieved
Clinical duration after first maintenance dose. DESCRIPTION: The time interval between the completion of injection of study drug and return of first twitch to 25%(as measured by TOF Watch Sx(R)) was defined as the clinical duration.
Time frame: Day of Surgery, after injection of study drug until return of first twitch to 25%
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 17 Apr 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rocuronium 0.6 mg/kg intubating dose, Rocuronium 0.9 mg/kg intubating dose and Rocuronium 0.1 mg/kg maintenance dose in people with Anesthesia, run by Merck Sharp & Dohme LLC.
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 5 inclusion and 2 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 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Onset time of intubating dose. DESCRIPTION: The time interval between the completion of injection of the study drug (rocuronium or vecuronium) and the maximal depression of first twitch--measured via TOF Watch Sx(R)-- was defined as the onset time. (time frame: Day of Surgery, after injection of study drug until maximal depression of first twitch achieved). 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 17 Apr 2015.