Neuromuscular BlockadeNCT03266419
Effectiveness of Deep Versus Moderate Neuromuscular Blockade
A study testing Deep NMB using rocuronium and Moderate NMB using rocuronium in people with Neuromuscular Blockade, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the influence of depth of neuromuscular blockade during laparoscopic gastrectomy on postoperative pain in surgical patients allocated randomly to either deep or moderate neuromuscular blockade group with standard-pressure pneumoperitoneum of 13 mmHg. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Deep NMB using rocuronium and Moderate NMB using rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2018to 2 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients 20 to 65 years old
- American Society of Anesthesiologist Physical Status 1, 2 or 3
- Patients undergoing laparoscopic gastrectomy
- Patients who signed a written informed consent form
Who cannot join
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
- Patients with known hypersensitivity to rocuronium or sugammadex
- Patient with VAS score (0=no pain; 100=the most severe pain) of at least 10 before surgery
- Patients with liver cirrhosis confirmed by abdominal CT
- Patients with neuromuscular disease that may interfere with neuromuscular data (ex. Duchenne muscular dystrophy, myasthenia gravis)
- Clinically significant impairment of cardiovascular function, defined by ejection fraction < 50%
Show all 17Show fewer
- Clinically significant impairment of renal function, defined by estimated GFR < 60 ml/min or need for hemodialysis
- Clinically significant impairment of liver function, defined by alanine aminotransferase > 100 IU/L
- Indication for rapid sequence induction
- Use of opioids within the 7 days prior to surgery
- History of abdominal surgery
- History of chronic obstructive pulmonary disease
- Body mass index (BMI) ≥ 35 kg/m2
- Body weight < 50 kg
- Conversion to laparotomy
- Family history of malignant hyperthermia
- Patients who are considered by the investigator to be unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Parallel Design to Compare the Effectiveness of Deep Versus Moderate Neuromuscular Blockade With Standard-pressure Pneumoperitoneum During Laparoscopic Gastrectomy on Postoperative Pain in Surgical Patients
The aim of this study is to evaluate the influence of depth of neuromuscular blockade during laparoscopic gastrectomy on postoperative pain in surgical patients allocated randomly to either deep or moderate neuromuscular blockade group with standard-pressure pneumoperitoneum of 13 mmHg.
Read the detailed description
- All patients were fasted from midnight without premedication
- Once in the operating room, the patients were monitored using electrocardiography, pulse oximetry, end-tidal carbon dioxide partial pressure, non-invasive blood pressure, and bispectral index (Aspect 2000; Aspect Medical Systems, Inc., Newton, MA, USA) measurements.
- Neuromuscular transmission was monitored using the M-NMT® module at the adductor pollicis muscle (Carescape® B850, GE Healthcare, Milwaukee, WI, USA).
- Throughout the surgery, these data were continuously downloaded to personal computers by using RS232C cables.
- Following pre-oxygenation with 100% O2, anesthesia was induced with propofol and remifentanil, which were administered using a target effect-site concentration-controlled infusion pump (Perfusor® Space, B. Braun Melsungen, Germany) by using the models suggested by Schnider et al. and Minto et al (Minto et al., 1997; Schnider et al., 1998).
- Tracheal intubation was facilitated with rocuronium 0.6 mg/kg.
- After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:1) and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 45 mmHg.
- For deep NMB group, an intravenous bolus of rocuronium (0.7 mg/kg) was given 2 minutes after intubation, followed by a continuous infusion of rocuronium of 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation. PTC was measured every 5 minutes. In the case of deviations from the target PTC, the pump speed could be increased or decreased or a bolus dose (10 mg) could be given.
- For moderate NMB group, no further loading dose of rocuronium was given. An intravenous infusion with rocuronium (0.2-0.6 mg/kg/h) was started at a TOF count of 1 for maintaining moderate NMB (train of four 1-2) during operation. TOF was measured every 5 minutes. In the case of deviations from the target TOF, the pump speed could be increased or decreased or a bolus dose (10 mg) could be given.
- The target effect-site concentrations of propofol were adjusted within a range of 2.5-3 μg/ml to maintain the bispectral index values at less than 60 during the induction and maintenance of anesthesia.
- The target effect-site concentrations of remifentanil were titrated to prevent signs of inadequate anesthesia and to maintain stable hemodynamics (SBP > 80 mmHg and HR > 45 beats/min).
- Signs of inadequate anesthesia: systemic arterial blood pressure increased to greater than 15 mm Hg higher than the patient's normal value; heart rate exceeding 90 beats/min in the absence of hypovolemia; somatic responses, such as body movements (minimal muscle paralysis allowed physical movement), swallowing, coughing, grimacing, or opening of the eyes; and autonomic signs of inadequate anesthesia (Ausems, Vuyk, Hug, \& Stanski, 1988)
- If necessary, ephedrine or atropine is administered to maintain systolic blood pressure above 80 mmHg and heart rate above 45 beats/min during anesthesia.
- An abdominal pressure of 13 mmHg was maintained during the laparoscopic surgery.
- When the surgeon asks for muscle relaxation due to the inability to obtain a visible laparoscopic field, additional bolus dose of rocuronium (10 mg) should be given.
- All patients were administered a bolus dose of oxycodone of 0.05 mg/kg at the end of pneumoperitoneum.
- IV PCA with oxycodone is started after the administration of loading dose. A semi-electronic pump (Automed 3200; Ace Medical, Seoul, South Korea) is used for PCA with demand bolus of 1 ml, background infusion of 1 ml/h and lock-out time of 15 min. The concentration of oxycodone in IV PCA bag is 1 mg/ml, and the volume of oxycodone-normal saline mixture delivered to patients for approximately 4 days is 200 ml.
- Rocuronium infusions are discontinued after deflation of CO2.
- After the end of surgery, a single intravenous bolus dose of sugammadex 2 or 4 mg/kg was administered for reversal of moderate and deep NMB, respectively.
- After the end of surgery, patients were taken to the PACU, and assessed for pain every 10 min using a VAS (0=no pain; 10=the most severe pain).
- Researchers who evaluate postoperative pain will be blinded to the patient's allocation
- Pain was measured at rest and when the wound areas were compressed with a force of 20 N (i.e., 2 kg of pressure imposed by three fingers on a 10 cm2 area). The wound compression was performed by a blinded researcher who was trained with an algometer (Commander Algometer, J Tech Medical Industries, Midvale, UT, USA) to apply this force consistently.
- The patient was administered intravenous oxycodone 2 mg (body weight <80 kg) or 3 mg (>80 kg) every 10 min until the VAS assessments showed that the pain intensity had decreased to <3 at rest and <5 on wound compression. At this point, MEAD of oxycodone was determined.
- VAS for wound and shoulder pain were also assessed at 6 and 24 h after the end of surgery.
- Postoperative nausea and vomiting were evaluated using the Rhodes index of nausea vomiting retching (RINVR) at 6 and 24 h after the end of surgery (Lee et al., 2016).
- After the end of surgery, the surgeon scored the surgical working conditions according to a five-point ordinal scale ranging from 1 (extremely poor conditions) to 5 (optimal conditions) (Martini et al., 2014).
- If the surgeon requests blind cessation for patient safety reasons, blindness is lifted.
- Conditions
- Neuromuscular Blockade
- Being tested
- Deep NMB using rocuronium, Moderate NMB using rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep NMB using rocuroniumDrug
- Drug: rocuronium
- Bolus dose: 0.7 mg/kg
- Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.
Moderate NMB using rocuroniumDrug
- Drug: rocuronium
- Bolus dose: none
- Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.
| Study group | Role | What they receive |
|---|---|---|
| Deep NMB using rocuronium | Experimental | The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation Receives: Drug: Deep NMB using rocuronium |
| Moderate NMB using rocuronium | Active comparator | The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation Receives: Drug: Moderate NMB using rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU)
The patient was administered intravenous oxycodone 2 mg (body weight <80 kg) or 3 mg (>80 kg) every 10 min until the VAS (visual analogue scale)assessments showed that the pain intensity had decreased to <3 at rest and <5 on wound compression. At this point, MEAD of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).
Measured: Through study period in PACU (post anesthesia care unit), up to 2 hours
Secondary outcomes (1)
Mean Visual Analogue Scale (VAS) Score for Wound Pain at Post Anesthesia Care Unit (PACU)
The patient was administered intravenous oxycodone 2 mg (body weight <80 kg) or 3 mg (>80 kg) every 10 min until the visual analogue scale (VAS) assessments showed that the pain intensity had decreased to <3 at rest and <5 on wound compression. At this point, the minimum effective analgesic dose (MEAD) of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).
Measured: Through study period in post anesthesia care unit (PACU), an average of about 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start28 Mar 2018
- Primary completion1 Nov 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is investigator-initiated, randomized, double blinded clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byung-Moon Choi, Asan Medical Center
- Investigators
- Byung-Moon Choi, Dr, Principal investigator, Department of Anesthesiology and Pain Medicine, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266419
- Sponsor's protocol ID
- 2017-0966
- Status last verified
- Oct 2019
- First submitted
- 21 Aug 2017
- Last updated
- 13 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because MSD provides research funding, the IPD of this study will not be shared with other researchers.
Publications
Choi BM, Ki SH, Lee YH, Gong CS, Kim HS, Lee IS, Kim BS, Kim BS, Noh GJ. Effects of depth of neuromuscular block on postoperative pain during laparoscopic gastrectomy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Nov;36(11):863-870. doi: 10.1097/EJA.0000000000001082.
PubMed 31503037
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel Design to Compare the Effectiveness of Deep Versus Moderate Neuromuscular Blockade With Standard-pressure Pneumoperitoneum During Laparoscopic Gastrectomy on Postoperative Pain in Surgical Patients
- ClinicalTrials.gov ID
- NCT03266419
- Acronym / sponsor ID
- 2017-0966
- Conditions
- Neuromuscular Blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the influence of depth of neuromuscular blockade during laparoscopic gastrectomy on postoperative pain in surgical patients allocated randomly to either deep or moderate neuromuscular blockade group with standard-pressure pneumoperitoneum of 13 mmHg.
Detailed description
- All patients were fasted from midnight without premedication
- Once in the operating room, the patients were monitored using electrocardiography, pulse oximetry, end-tidal carbon dioxide partial pressure, non-invasive blood pressure, and bispectral index (Aspect 2000; Aspect Medical Systems, Inc., Newton, MA, USA) measurements.
- Neuromuscular transmission was monitored using the M-NMT® module at the adductor pollicis muscle (Carescape® B850, GE Healthcare, Milwaukee, WI, USA).
- Throughout the surgery, these data were continuously downloaded to personal computers by using RS232C cables.
- Following pre-oxygenation with 100% O2, anesthesia was induced with propofol and remifentanil, which were administered using a target effect-site concentration-controlled infusion pump (Perfusor® Space, B. Braun Melsungen, Germany) by using the models suggested by Schnider et al. and Minto et al (Minto et al., 1997; Schnider et al., 1998).
- Tracheal intubation was facilitated with rocuronium 0.6 mg/kg.
- After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:1) and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 45 mmHg.
- For deep NMB group, an intravenous bolus of rocuronium (0.7 mg/kg) was given 2 minutes after intubation, followed by a continuous infusion of rocuronium of 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation. PTC was measured every 5 minutes. In the case of deviations from the target PTC, the pump speed could be increased or decreased or a bolus dose (10 mg) could be given.
- For moderate NMB group, no further loading dose of rocuronium was given. An intravenous infusion with rocuronium (0.2-0.6 mg/kg/h) was started at a TOF count of 1 for maintaining moderate NMB (train of four 1-2) during operation. TOF was measured every 5 minutes. In the case of deviations from the target TOF, the pump speed could be increased or decreased or a bolus dose (10 mg) could be given.
- The target effect-site concentrations of propofol were adjusted within a range of 2.5-3 μg/ml to maintain the bispectral index values at less than 60 during the induction and maintenance of anesthesia.
- The target effect-site concentrations of remifentanil were titrated to prevent signs of inadequate anesthesia and to maintain stable hemodynamics (SBP > 80 mmHg and HR > 45 beats/min).
- Signs of inadequate anesthesia: systemic arterial blood pressure increased to greater than 15 mm Hg higher than the patient's normal value; heart rate exceeding 90 beats/min in the absence of hypovolemia; somatic responses, such as body movements (minimal muscle paralysis allowed physical movement), swallowing, coughing, grimacing, or opening of the eyes; and autonomic signs of inadequate anesthesia (Ausems, Vuyk, Hug, \& Stanski, 1988)
- If necessary, ephedrine or atropine is administered to maintain systolic blood pressure above 80 mmHg and heart rate above 45 beats/min during anesthesia.
- An abdominal pressure of 13 mmHg was maintained during the laparoscopic surgery.
- When the surgeon asks for muscle relaxation due to the inability to obtain a visible laparoscopic field, additional bolus dose of rocuronium (10 mg) should be given.
- All patients were administered a bolus dose of oxycodone of 0.05 mg/kg at the end of pneumoperitoneum.
- IV PCA with oxycodone is started after the administration of loading dose. A semi-electronic pump (Automed 3200; Ace Medical, Seoul, South Korea) is used for PCA with demand bolus of 1 ml, background infusion of 1 ml/h and lock-out time of 15 min. The concentration of oxycodone in IV PCA bag is 1 mg/ml, and the volume of oxycodone-normal saline mixture delivered to patients for approximately 4 days is 200 ml.
- Rocuronium infusions are discontinued after deflation of CO2.
- After the end of surgery, a single intravenous bolus dose of sugammadex 2 or 4 mg/kg was administered for reversal of moderate and deep NMB, respectively.
- After the end of surgery, patients were taken to the PACU, and assessed for pain every 10 min using a VAS (0=no pain; 10=the most severe pain).
- Researchers who evaluate postoperative pain will be blinded to the patient's allocation
- Pain was measured at rest and when the wound areas were compressed with a force of 20 N (i.e., 2 kg of pressure imposed by three fingers on a 10 cm2 area). The wound compression was performed by a blinded researcher who was trained with an algometer (Commander Algometer, J Tech Medical Industries, Midvale, UT, USA) to apply this force consistently.
- The patient was administered intravenous oxycodone 2 mg (body weight <80 kg) or 3 mg (>80 kg) every 10 min until the VAS assessments showed that the pain intensity had decreased to <3 at rest and <5 on wound compression. At this point, MEAD of oxycodone was determined.
- VAS for wound and shoulder pain were also assessed at 6 and 24 h after the end of surgery.
- Postoperative nausea and vomiting were evaluated using the Rhodes index of nausea vomiting retching (RINVR) at 6 and 24 h after the end of surgery (Lee et al., 2016).
- After the end of surgery, the surgeon scored the surgical working conditions according to a five-point ordinal scale ranging from 1 (extremely poor conditions) to 5 (optimal conditions) (Martini et al., 2014).
- If the surgeon requests blind cessation for patient safety reasons, blindness is lifted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is investigator-initiated, randomized, double blinded clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Deep NMB using rocuronium | Experimental | Drug: Deep NMB using rocuroniumThe abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation |
| Moderate NMB using rocuronium | Active comparator | Drug: Moderate NMB using rocuroniumThe abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 20 to 65 years old
- American Society of Anesthesiologist Physical Status 1, 2 or 3
- Patients undergoing laparoscopic gastrectomy
- Patients who signed a written informed consent form
Key exclusion criteria (17 listed)
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
- Patients with known hypersensitivity to rocuronium or sugammadex
- Patient with VAS score (0=no pain; 100=the most severe pain) of at least 10 before surgery
- Patients with liver cirrhosis confirmed by abdominal CT
- Patients with neuromuscular disease that may interfere with neuromuscular data (ex. Duchenne muscular dystrophy, myasthenia gravis)
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 |
|---|---|---|
| Deep NMB using rocuronium* Drug: rocuronium * Bolus dose: 0.7 mg/kg * Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation. | Drug | Deep NMB using rocuronium |
| Moderate NMB using rocuronium* Drug: rocuronium * Bolus dose: none * Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation. | Drug | Moderate NMB using rocuronium |
Primary outcome
Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU)
Time frame: Through study period in PACU (post anesthesia care unit), up to 2 hours
The patient was administered intravenous oxycodone 2 mg (body weight <80 kg) or 3 mg (>80 kg) every 10 min until the VAS (visual analogue scale)assessments showed that the pain intensity had decreased to <3 at rest and <5 on wound compression. At this point, MEAD of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).
1 secondary outcome
Mean Visual Analogue Scale (VAS) Score for Wound Pain at Post Anesthesia Care Unit (PACU)
Time frame: Through study period in post anesthesia care unit (PACU), an average of about 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31503037Choi BM, Ki SH, Lee YH, Gong CS, Kim HS, Lee IS, Kim BS, Kim BS, Noh GJ. Effects of depth of neuromuscular block on postoperative pain during laparoscopic gastrectomy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Nov;36(11):863-870. doi: 10.1097/EJA.0000000000001082.
- Individual participant dataSharing planned: No. Because MSD provides research funding, the IPD of this study will not be shared with other researchers.
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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.
Byung-Moon Choi, Dr principal investigator
Department of Anesthesiology and Pain Medicine, Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep NMB using rocuronium and Moderate NMB using rocuronium in people with Neuromuscular Blockade, run by Asan Medical Center 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 4 inclusion and 17 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 13 Nov 2019. 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. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU) (time frame: Through study period in PACU (post anesthesia care unit), up to 2 hours). 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 NCT03266419, which also lists 1 linked publication.
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 13 Nov 2019.