Neuromuscular BlockadeNCT02510157
Effect of Dexamethasone on the Action of Sugammadex
A study testing Dexamethasone, Normal Saline and sugammadex in people with Neuromuscular Blockade, run by Attikon Hospital at 1 site in Greece.
Trial summary
This study aims to investigate the possible clinical effect of dexamethasone on the action of sugammadex when it is administered to reverse deep neuromuscular blockade caused by rocuronium in laparoscopic cholecystectomies. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Dexamethasone, Normal Saline and sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGreece
- Study dates
- May 2015to Sep 2016
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients aged 18-70 years
- laparoscopic cholecystectomy
- operation < 3 hours
Who cannot join
- age <18 or >70 years old
- ASA physical status >3
- central nervous system diseases
- severe psychiatric disorders under treatment
- cognitive dysfunction
- known or suspected allergy to the administered drugs
Show all 14Show fewer
- operations > 3 hours
- surgical intraoperative complications-open cholecystectomy
- severe renal or liver disease
- diabetes melitus
- immunosuppressed patients
- chronic immunosuppresant therapy (corticosteroids or other drugs)
- all contraindications to corticosteroids administration
- patiens on chronic use of opioids
Trial locations and contacts
1 site in 1 country.
Greece1 site
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, 12462
About this study
This study aims to investigate the possible clinical effect of dexamethasone on the action of sugammadex when it is administered to reverse deep neuromuscular blockade caused by rocuronium in laparoscopic cholecystectomies.
- Conditions
- Neuromuscular Blockade
- Being tested
- Dexamethasone, Normal Saline, sugammadex
- Keywords
- sugammadex, dexamethasone, neuromuscular blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
active comparator
Normal SalineDrug
Also called N/S 0.9%
placebo controlled intervention
sugammadexDrug
sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone | Active comparator | Dexamethasone is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade. Receives: Drug: Dexamethasone; Drug: sugammadex |
| normal saline | Placebo comparator | Normal saline is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade. Receives: Drug: Normal Saline; Drug: sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex
measurement of time after administration of the reversal agent (sugammadex) to achieve train-of-four (TOF0 ratio of 0.9 (up to 30 minutes)
Measured: minutes after administration of sugammadex (0 to 30 minutes)
Secondary outcomes (2)
Postoperative pain
Assessed by Numeric Rating Scale 0-10
Measured: 1, 6, 12, 24 hours postoperatively
Postoperative nausea and vomiting
Assessed by nausea/vomiting scale (11. Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth 2012; 108: 423-429)
Measured: 1, 6, 12, 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2016
- Study completionSep 2016
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrysanthi Batistaki, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510157
- Sponsor's protocol ID
- 711/19-3-15
- Status last verified
- Jul 2016
- First submitted
- 16 May 2015
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone on the Action of Sugammadex
- ClinicalTrials.gov ID
- NCT02510157
- Acronym / sponsor ID
- 711/19-3-15
- Conditions
- Neuromuscular Blockade
- Keywords
- sugammadex, dexamethasone, neuromuscular blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Jul 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.
This study aims to investigate the possible clinical effect of dexamethasone on the action of sugammadex when it is administered to reverse deep neuromuscular blockade caused by rocuronium in laparoscopic cholecystectomies.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | Active comparator | Drug: Dexamethasone, Drug: sugammadexDexamethasone is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade. |
| normal saline | Placebo comparator | Drug: Normal Saline, Drug: sugammadexNormal saline is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged 18-70 years
- laparoscopic cholecystectomy
- operation < 3 hours
Key exclusion criteria (14 listed)
- age <18 or >70 years old
- ASA physical status >3
- central nervous system diseases
- severe psychiatric disorders under treatment
- cognitive 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 |
|---|---|---|
| Dexamethasoneactive comparator | Drug | dexamethasone |
| Normal SalineAlso: N/S 0.9%placebo controlled intervention | Drug | normal saline |
| sugammadexsugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery | Drug | dexamethasone, normal saline |
Primary outcome
Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex
Time frame: minutes after administration of sugammadex (0 to 30 minutes)
measurement of time after administration of the reversal agent (sugammadex) to achieve train-of-four (TOF0 ratio of 0.9 (up to 30 minutes)
2 secondary outcomes
Postoperative pain
Time frame: 1, 6, 12, 24 hours postoperatively
Postoperative nausea and vomiting
Time frame: 1, 6, 12, 24 hours postoperatively
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 4 Oct 2016.
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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 study testing Dexamethasone, Normal Saline and sugammadex in people with Neuromuscular Blockade, run by Attikon Hospital at 1 site in Greece.
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 3 inclusion and 14 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 4 Oct 2016. 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 Greece. 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. Some participants in this study may receive a placebo. 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?
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?
Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex (time frame: minutes after administration of sugammadex (0 to 30 minutes)). 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 4 Oct 2016.