Patients Undergoing Laparoscopic SurgeryPhase 4NCT03371953
Evaluation of Atracurium-vecuronium Combination in Laparosocpic Surgery
A Phase 4 study testing Vecuronium, Atracurium and Vecuronium + Atracurium in people with Patients Undergoing Laparoscopic Surgery, run by Sir Ganga Ram Hospital at 1 site in India.
Trial summary
Non-depolarising muscle relaxants are routinely employed to provide skeletal muscle relaxation during general anaesthesia (GA). Generally investigators use one or the other type of relaxant agent for this purpose and they are categorised based on their duration-of-action. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patients Undergoing Laparoscopic Surgery
- What is being tested?
- Vecuronium, Atracurium and Vecuronium + Atracurium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 20 Dec 2017to 25 Oct 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I and II
- Laparoscopic surgeries likely to last for 1 hour duration
Who cannot join
- Patient refusal
- ASA physical status III and IV
- History of hypersensitivity to atracurium or vecuronium
- Alcoholism and drug addiction
- Neuromuscular disorders
- Neuropsychiatric patients
Show all 10Show fewer
- Hepatic and renal disease patients
- Obese patients
- Abnormal airway anatomy
- Risk of oesophageal reflux
Trial locations and contacts
1 site in 1 country.
India1 site
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Amitabh Dutta, MD, PGDHR, 00919810848064, duttaamiatbh@yahoo.co.in
Palem Reshmika, MBBS, 00919773587847, reshmika.palem@gmail.com
About this study
Official title: Efficacy of Atracurium-vecuronium Combination in Patients Undergoing Laparoscopic Surgery:a Randomised Controlled Study
Non-depolarising muscle relaxants are routinely employed to provide skeletal muscle relaxation during general anaesthesia (GA). Generally investigators use one or the other type of relaxant agent for this purpose and they are categorised based on their duration-of-action. Atracurium and vecuronium are two common muscle relaxant used during GA. They have an intermediate duration of action (around 40 minutes). Though they are effective relaxants and easy to reverse with reversal agents after the surgery, in case of the common laparoscopy procedures lasting an hour, they are relatively inefficient. There is evidence that when these agents are combined together (in 1:1 ratio), the duration-of-action, and reversibility improves. To render atracurium and vecuronium more efficient with laparoscopic surgery, the proposed study is aimed to evaluate the effects of combining 1/2 the respective standard doses of atracurium and vecuronium given together, in terms of its effect on the onset of block, duration-of-action, and reversibility of the neuromuscular blockade in adults undergoing laparoscopic surgery under GA. The study will be conducted with objective assessment parameter evaluation by TOF Watch SX (Organon, Teknica BV, Boxtel, The Netherlands), which will be used for facilitating institution, control, and monitoring the neuromuscular blockade during surgery. The objective of this study is to evaluate the additive effect of atracurium-vecuronium combination and profile its impact in patients undergoing laparoscopic surgery, especially in terms of increase in duration-of-action of muscle relaxation with the combination of drugs, when compared to respective individual drugs.
Read the detailed description
The principal pharmacological effect of neuromuscular blocking drugs is to interrupt the transmission of nerve impulses at the neuromuscular junction. They are classified into depolarising (mimics the action of acetylcholine) and non-depolarising (interfere with the action of acetylcholine).In general, we use vecuronium (0.08mg/kg) or atracurium (0.5mg/kg), which are intermediate-acting non-depolarising neuromuscular blocking agents for skeletal muscle relaxation.
The main use of neuromuscular blocking drugs is to provide skeletal muscle relaxation for facilitation of intubation of the trachea and to improve surgical working conditions in the anaesthetised patients. A 2×ED95 dose of non-depolarising muscle relaxant is recommended to facilitate tracheal intubation. In practice, 90% suppression of the single twitch response is usually considered clinical evidence of adequate drug-induced skeletal muscle relaxation.
Laparoscopy has become the most preferred means of surgical access for a variety of procedures. There are many laparoscopic surgeries that last about an hour. But the duration-of-action of bolus (intubating) dose of atracurium or vecuronium when used alone is not sufficient to last for an hour. As a result, for surgeries lasting an hour(e.g. laparoscopic cholecystectomy, laparoscopic total extra-peritoneal repair, etc.), one either end up giving a top up (maintenance) dose of vecuronium/atracurium to extend muscle relaxation or withhold the add-on dose and continue with surgery towards completion. While in the former situation, the anaesthesiologist is required to wait for long even though the surgery is completed; in the latter, either the surgery gets disturbed due to patient's movement (e.g. coughing, bucking) or there may be associated hemodynamic activation, which requires deepening of anaesthesia plane; both harbinger for patient-related adversity.
There are studies which have evaluated the effect of combining two non-depolarizing neuromuscular relaxants on the profile of skeletal muscle relaxation pertinent to anaesthetic (tracheal intubation) and surgical conditions.Atracurium and vecuronium are the most common non- depolarizing muscle relaxants we routinely employ during general anaesthesia (GA). Till date, to our knowledge, there are a very few studies that have evaluated combination of atracurium and vecuronium given together.Though, the limited number of studies which analysed effects of combined neuromuscular relaxation with atracurium and vecuronium underlined that there is an additive effect, commented only on onset-of-action and reversibility of muscle relaxation effect. In addition, no study has yet evaluated the duration-of-action of atracurium- vecuronium combination in adults undergoing laparoscopic surgeries. Muscle relaxation is used for optimising laparoscopic operating conditions by preventing diaphragmatic movement due to irritation by the presence of pneumoperitoneum and achieving more intra-abdominal space for a particular intra-abdominal insufflation pressure. In this context, deeper than normally maintained level of neuromuscular blockade appears to be superior. The investigators contend that combining vecuronium and atracurium would not only facilitate increase in duration-of-action of the relaxation but also provide quality muscle relaxation for the duration of surgery.
The proposed study looks forward to analyse the effect of muscle relaxation profile of vecuronium-atracurium combination versus vecuronium-alone or atracurium-alone in patients undergoing laparoscopic surgery.
- Conditions
- Patients Undergoing Laparoscopic Surgery
- Being tested
- Vecuronium, Atracurium, Vecuronium + Atracurium
- Keywords
- vecuronium, atracurium, combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VecuroniumDrug
A top-up dose of vecuronium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count.
AtracuriumDrug
A top-up dose of vecuronium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count.
Vecuronium + AtracuriumDrug
A top-up dose of vecuronium + atracurium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count.
| Study group | Role | What they receive |
|---|---|---|
| Vecuronium group | Active comparator | Vecuronium 0.08 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation Receives: Drug: Vecuronium |
| Atracurium group | Active comparator | Atracurium 0.6 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation Receives: Drug: Atracurium |
| Vecuronium-Atracurium group | Active comparator | Vecuronium 0.04 mg/kg + atracurium 0.3 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation Receives: Drug: Vecuronium + Atracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration-of-action of the intubating dose
Duration of action will be calculated from the time the drug is administered till theTOF count is 1 on the accelerometer.
Measured: From the time of administration of (0-hours, baseline) till 60-minutes intraoperatively
Secondary outcomes (3)
Onset-of-action of muscle relaxation following intubating dose
Onset-of-action will be calculated from the time the drug is administered till theTOF count is 0 on the accelerometer.
Measured: From the time of administration of (0-hours, baseline) till 5-minutes intraoperatively
Qualitative intubating conditions.
Quality of intubating condition will be assessed using 3-point modified Cooper's scale. The intubating conditions will be graded as excellent, good \& poor.
- The scale "Intubating conditions following intubating dose of non-depolarizing muscle relaxant" is modified from Cooper's Scale. The scale's name is derived from the name of the investigator (Cooper R) who first used it. (Br J Anaesth 1992; 69: 269-73)
- The Cooper Scale includes five major variable sets [1. Laryngoscopy (Jaw Relaxation), 2.Vocal-cord position, 3. Vocal cord movement, 4. Reaction to intubation and/or cuff inflation 5. Movement of limbs/ coughing] which are classified as poor, good or excellent. For ease of the study analysis, poor is scored '0', good is scored '1', and excellent is scored '2'. Therefore, each variable has subscale range of 0-2 and, five variables are together ranged as 0-10.
- Each of the five subscale range, i. e. 0-2, are added up to gain a 'total scale range score' of 0-10.
Measured: From the time of administration of (0-hours, baseline) till 5-minutes intraoperatively
Reversibility of muscle relaxant effect
Time for complete reversal of effect of muscle relaxation will be determined from the time of administration of reversal agent till the the point when TOF ratio is 90-percent.
Measured: From the time of administration of (0-hours, baseline) till 5-minutes post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start20 Dec 2017 (estimated)
- Primary completion25 Oct 2018 (estimated)
- Study completion25 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Laparoscopic SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly divided into three groups in a 1:1:1 distribution undertaken by a computer-generated random number system. Vecuronium group - 0.08mg/kg vecuronium alone Atracurium group- 0.6mg/kg atracurium alone Vecuronium-atracurium group- 0.04mg/kg vecuronium and 0.3 mg/kg atracurium combination
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amitabh Dutta, Sir Ganga Ram Hospital
- Investigators
- Amitabh Dutta, MD,PGDHR, Study chair, Sir Ganga Ram HospitalSubhash Gupta, MD, Study director, Sir Ganga Ram HospitalSavitar Malhotra, MD, Principal investigator, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371953
- Sponsor's protocol ID
- EC/10/17/1280
- Status last verified
- Dec 2017
- First submitted
- 2 Dec 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Atracurium-vecuronium Combination in Patients Undergoing Laparoscopic Surgery:a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03371953
- Acronym / sponsor ID
- EC/10/17/1280
- Conditions
- Patients Undergoing Laparoscopic Surgery
- Keywords
- vecuronium, atracurium, combination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 20 Dec 2017 (estimated)
- Primary completion
- 25 Oct 2018 (estimated)
- Study completion
- 25 Oct 2018 (estimated)
- First posted
- 13 Dec 2017 (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.
Non-depolarising muscle relaxants are routinely employed to provide skeletal muscle relaxation during general anaesthesia (GA). Generally investigators use one or the other type of relaxant agent for this purpose and they are categorised based on their duration-of-action. Atracurium and vecuronium are two common muscle relaxant used during GA. They have an intermediate duration of action (around 40 minutes). Though they are effective relaxants and easy to reverse with reversal agents after the surgery, in case of the common laparoscopy procedures lasting an hour, they are relatively inefficient. There is evidence that when these agents are combined together (in 1:1 ratio), the duration-of-action, and reversibility improves. To render atracurium and vecuronium more efficient with laparoscopic surgery, the proposed study is aimed to evaluate the effects of combining 1/2 the respective standard doses of atracurium and vecuronium given together, in terms of its effect on the onset of block, duration-of-action, and reversibility of the neuromuscular blockade in adults undergoing laparoscopic surgery under GA. The study will be conducted with objective assessment parameter evaluation by TOF Watch SX (Organon, Teknica BV, Boxtel, The Netherlands), which will be used for facilitating institution, control, and monitoring the neuromuscular blockade during surgery. The objective of this study is to evaluate the additive effect of atracurium-vecuronium combination and profile its impact in patients undergoing laparoscopic surgery, especially in terms of increase in duration-of-action of muscle relaxation with the combination of drugs, when compared to respective individual drugs.
Detailed description
The principal pharmacological effect of neuromuscular blocking drugs is to interrupt the transmission of nerve impulses at the neuromuscular junction. They are classified into depolarising (mimics the action of acetylcholine) and non-depolarising (interfere with the action of acetylcholine).In general, we use vecuronium (0.08mg/kg) or atracurium (0.5mg/kg), which are intermediate-acting non-depolarising neuromuscular blocking agents for skeletal muscle relaxation.
The main use of neuromuscular blocking drugs is to provide skeletal muscle relaxation for facilitation of intubation of the trachea and to improve surgical working conditions in the anaesthetised patients. A 2×ED95 dose of non-depolarising muscle relaxant is recommended to facilitate tracheal intubation. In practice, 90% suppression of the single twitch response is usually considered clinical evidence of adequate drug-induced skeletal muscle relaxation.
Laparoscopy has become the most preferred means of surgical access for a variety of procedures. There are many laparoscopic surgeries that last about an hour. But the duration-of-action of bolus (intubating) dose of atracurium or vecuronium when used alone is not sufficient to last for an hour. As a result, for surgeries lasting an hour(e.g. laparoscopic cholecystectomy, laparoscopic total extra-peritoneal repair, etc.), one either end up giving a top up (maintenance) dose of vecuronium/atracurium to extend muscle relaxation or withhold the add-on dose and continue with surgery towards completion. While in the former situation, the anaesthesiologist is required to wait for long even though the surgery is completed; in the latter, either the surgery gets disturbed due to patient's movement (e.g. coughing, bucking) or there may be associated hemodynamic activation, which requires deepening of anaesthesia plane; both harbinger for patient-related adversity.
There are studies which have evaluated the effect of combining two non-depolarizing neuromuscular relaxants on the profile of skeletal muscle relaxation pertinent to anaesthetic (tracheal intubation) and surgical conditions.Atracurium and vecuronium are the most common non- depolarizing muscle relaxants we routinely employ during general anaesthesia (GA). Till date, to our knowledge, there are a very few studies that have evaluated combination of atracurium and vecuronium given together.Though, the limited number of studies which analysed effects of combined neuromuscular relaxation with atracurium and vecuronium underlined that there is an additive effect, commented only on onset-of-action and reversibility of muscle relaxation effect. In addition, no study has yet evaluated the duration-of-action of atracurium- vecuronium combination in adults undergoing laparoscopic surgeries. Muscle relaxation is used for optimising laparoscopic operating conditions by preventing diaphragmatic movement due to irritation by the presence of pneumoperitoneum and achieving more intra-abdominal space for a particular intra-abdominal insufflation pressure. In this context, deeper than normally maintained level of neuromuscular blockade appears to be superior. The investigators contend that combining vecuronium and atracurium would not only facilitate increase in duration-of-action of the relaxation but also provide quality muscle relaxation for the duration of surgery.
The proposed study looks forward to analyse the effect of muscle relaxation profile of vecuronium-atracurium combination versus vecuronium-alone or atracurium-alone in patients undergoing laparoscopic surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomly divided into three groups in a 1:1:1 distribution undertaken by a computer-generated random number system. Vecuronium group - 0.08mg/kg vecuronium alone Atracurium group- 0.6mg/kg atracurium alone Vecuronium-atracurium group- 0.04mg/kg vecuronium and 0.3 mg/kg atracurium combination
| Arm | Type | Receives |
|---|---|---|
| Vecuronium group | Active comparator | Drug: VecuroniumVecuronium 0.08 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation |
| Atracurium group | Active comparator | Drug: AtracuriumAtracurium 0.6 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation |
| Vecuronium-Atracurium group | Active comparator | Drug: Vecuronium + AtracuriumVecuronium 0.04 mg/kg + atracurium 0.3 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status I and II
- Laparoscopic surgeries likely to last for 1 hour duration
Key exclusion criteria (10 listed)
- Patient refusal
- ASA physical status III and IV
- History of hypersensitivity to atracurium or vecuronium
- Alcoholism and drug addiction
- 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 |
|---|---|---|
| VecuroniumA top-up dose of vecuronium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count. | Drug | Vecuronium group |
| AtracuriumA top-up dose of vecuronium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count. | Drug | Atracurium group |
| Vecuronium + AtracuriumA top-up dose of vecuronium + atracurium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count. | Drug | Vecuronium-Atracurium group |
Primary outcome
Duration-of-action of the intubating dose
Time frame: From the time of administration of (0-hours, baseline) till 60-minutes intraoperatively
Duration of action will be calculated from the time the drug is administered till theTOF count is 1 on the accelerometer.
3 secondary outcomes
Onset-of-action of muscle relaxation following intubating dose
Time frame: From the time of administration of (0-hours, baseline) till 5-minutes intraoperatively
Qualitative intubating conditions.
Time frame: From the time of administration of (0-hours, baseline) till 5-minutes intraoperatively
Reversibility of muscle relaxant effect
Time frame: From the time of administration of (0-hours, baseline) till 5-minutes post administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Amitabh Dutta, MD,PGDHR study chair
Sir Ganga Ram Hospital
Subhash Gupta, MD study director
Sir Ganga Ram Hospital
Savitar Malhotra, MD principal investigator
Sir Ganga Ram Hospital
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 Vecuronium, Atracurium and Vecuronium + Atracurium in people with Patients Undergoing Laparoscopic Surgery, run by Sir Ganga Ram Hospital at 1 site in India.
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: status not confirmed, as of the sponsor's last update on 14 Dec 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amitabh Dutta, MD,PGDHR (00919810848064, duttaamiatbh@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration-of-action of the intubating dose (time frame: From the time of administration of (0-hours, baseline) till 60-minutes intraoperatively). 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 14 Dec 2017.