Neuromuscular Blockade Reversal AgentPhase 4NCT04332627
Comparison of QoR-15 in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine
A Phase 4 study testing Sugammadex and Neostigmine in people with Neuromuscular Blockade Reversal Agent and Sugammadex, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The quality of recovery in patients who were reversed neuromuscular blockade by using Sumamadex and Neostigmine in laparoscopic cholecystectomy was compared through the QoR(Quality of Recovery)-15 questionnaire. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Neuromuscular Blockade Reversal Agent, Sugammadex, Neostigmine
- What is being tested?
- Sugammadex and Neostigmine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Feb 2020to 21 May 2020
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who underwent laparoscopic cholecystectomy aged 20-70
Who cannot join
- neuromuscular disease
- allergy to rocuronium, sugammadex, neostigmine
- cognitive impairment ( disable to answer the questionnaire )
- refuse to participate
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Comparison of Quality of Recovery Score (QoR-15) According to Neuromuscular Blocking Reversal Agent in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine
The quality of recovery in patients who were reversed neuromuscular blockade by using Sumamadex and Neostigmine in laparoscopic cholecystectomy was compared through the QoR(Quality of Recovery)-15 questionnaire.
Read the detailed description
Quality of Recovery questionnaire includes five details (Emotional status, Physical comfort, Physiological support, Physical independece, Pain), and is a proven method of reliability, consistency and validity for evaluating recovery from surgery and anesthesia.
After laparoscopic cholecystectomy, patients experience various discomforts such as pain, nausea, vomiting, and placebo due to general anesthesia.
Neostigmine has side effects such as crampy abdominal pain, nausea and vomiting. In addition, residual neuromuscular blockade was higher in neostigmine compared with sugammadex.
Although sugammadex expected to improve patient's recovery, it is still controversial that sugammadex contributes to clinically meaningfull difference compared with neostigmine.
Therefore, the aim of our study is comparison of quality of recovery through QoR-15 questionnaire in patients who were reversed neuromuscular blockade by using sugammadex and neostigmine in laparoscopic cholecystectomy.
- Conditions
- Neuromuscular Blockade Reversal Agent, Sugammadex, Neostigmine, Quality of Recovery, Laparoscopic Cholecystectomy
- Being tested
- Sugammadex, Neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg)
NeostigmineDrug
with glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| sugammadex | Active comparator | sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg) Receives: Drug: Sugammadex |
| neostigmine | Placebo comparator | with glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg) Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery(QoR)-15 questionnaire score
the difference of Quality of Recovery(QoR)-15 score between preoperative and postoperative 1 and 2 days (minimum value : 0, maximum value : 150, the higher the score, the better the result)
Measured: preoperative 1 days to postoperative 2 days
Secondary outcomes (6)
recovery time
from injection of sugammadex or neostigmien to extubation and confirm of adequate spontaneous breathing
Measured: perioperative - until 48hours
PACU(post-anesthesia care unit) stay time
from entry of PACU to go general ward
Measured: perioperative - until 48hours
postoperative pain score
postoperative pain score measured by 11-point NRS(numerical rating scale) score (minimum : 0, maximum : 11, the lower the score, the lesser pain)
Measured: at postoperative 30minutes, 6hours, 24hours
the incidence of administration of postoperative rescue drug
administration of analgesic drug and anti-emetic drug for postoperative management
Measured: perioperative - until 72hours
hospital stay
days of hospital stay
Measured: preoperative - until discharge (usually 48 hours to 72hours)
urinary retention
residual urine > 300ml diagnosed by bladder ultrasonography
Measured: postoperative - until discharge (usually 48 hours to 72hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start24 Feb 2020
- Primary completion21 May 2020
- Study completion21 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Blockade Reversal AgentStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiWon Han, Seoul National University Bundang Hospital
- Investigators
- Jiwon Han, Ms, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332627
- Sponsor's protocol ID
- B-1910/571-004
- Status last verified
- Dec 2020
- First submitted
- 1 Apr 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
PubMed 23411725Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.
PubMed 28806470
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Recovery Score (QoR-15) According to Neuromuscular Blocking Reversal Agent in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine
- ClinicalTrials.gov ID
- NCT04332627
- Acronym / sponsor ID
- B-1910/571-004
- Conditions
- Neuromuscular Blockade Reversal Agent, Sugammadex, Neostigmine, Quality of Recovery, Laparoscopic Cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 21 May 2020 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 2 Apr 2020 (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.
The quality of recovery in patients who were reversed neuromuscular blockade by using Sumamadex and Neostigmine in laparoscopic cholecystectomy was compared through the QoR(Quality of Recovery)-15 questionnaire.
Detailed description
Quality of Recovery questionnaire includes five details (Emotional status, Physical comfort, Physiological support, Physical independece, Pain), and is a proven method of reliability, consistency and validity for evaluating recovery from surgery and anesthesia.
After laparoscopic cholecystectomy, patients experience various discomforts such as pain, nausea, vomiting, and placebo due to general anesthesia.
Neostigmine has side effects such as crampy abdominal pain, nausea and vomiting. In addition, residual neuromuscular blockade was higher in neostigmine compared with sugammadex.
Although sugammadex expected to improve patient's recovery, it is still controversial that sugammadex contributes to clinically meaningfull difference compared with neostigmine.
Therefore, the aim of our study is comparison of quality of recovery through QoR-15 questionnaire in patients who were reversed neuromuscular blockade by using sugammadex and neostigmine in laparoscopic cholecystectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugammadex | Active comparator | Drug: Sugammadexsugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg) |
| neostigmine | Placebo comparator | Drug: Neostigminewith glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who underwent laparoscopic cholecystectomy aged 20-70
Key exclusion criteria (4 listed)
- neuromuscular disease
- allergy to rocuronium, sugammadex, neostigmine
- cognitive impairment ( disable to answer the questionnaire )
- refuse to participate
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 |
|---|---|---|
| Sugammadexsugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg) | Drug | sugammadex |
| Neostigminewith glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg) | Drug | neostigmine |
Primary outcome
Quality of Recovery(QoR)-15 questionnaire score
Time frame: preoperative 1 days to postoperative 2 days
the difference of Quality of Recovery(QoR)-15 score between preoperative and postoperative 1 and 2 days (minimum value : 0, maximum value : 150, the higher the score, the better the result)
6 secondary outcomes
recovery time
Time frame: perioperative - until 48hours
PACU(post-anesthesia care unit) stay time
Time frame: perioperative - until 48hours
postoperative pain score
Time frame: at postoperative 30minutes, 6hours, 24hours
the incidence of administration of postoperative rescue drug
Time frame: perioperative - until 72hours
hospital stay
Time frame: preoperative - until discharge (usually 48 hours to 72hours)
urinary retention
Time frame: postoperative - until discharge (usually 48 hours to 72hours)
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 24 Dec 2020.
- Background: PubMed 23411725Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Background: PubMed 28806470Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.
- Individual participant dataSharing planned: No
Related trials for Neuromuscular Blockade Reversal Agent
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Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery, Reversing Rocuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery
Not yet recruitingPhase 4
A Dose-response Study to Determine the Right Dosage of Sugammadex as a Reversal Agent of Rocuronium in Infants Between 1 and 24 Months Old
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NMBA Reversal and Postoperative Urinary Retention
Neuromuscular Blocking Agents, Urinary Retention After Procedure
Active, not recruitingPhase 4
Reversal of Pipecuronium-induced Neuromuscular Blockade With Sugammadex During Propofol Anesthesia
Neuromuscular Blocking Agents, Residual Neuromuscular Block
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.
Jiwon Han, Ms principal investigator
Seoul National University Bundang 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 Sugammadex and Neostigmine in people with Neuromuscular Blockade Reversal Agent and Sugammadex, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 4 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 24 Dec 2020. 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 South Korea. 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.
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(QoR)-15 questionnaire score (time frame: preoperative 1 days to postoperative 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332627, which also lists 2 linked publications.
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 24 Dec 2020.