Trial Outcomes & Findings for Muscle Relaxation for Pediatric Adenotonsillectomy (NCT NCT06225466)
NCT ID: NCT06225466
Last Updated: 2025-07-28
Results Overview
Continuous outcome of intravenous morphine milligram equivalents (MME) per kg of body weight
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
172 participants
Primary outcome timeframe
From surgery start to discharge home, up to 24 hours
Results posted on
2025-07-28
Participant Flow
Participant milestones
| Measure |
Neuromuscular Blockade
Rocuronium 0.6 mg/kg IV (max 50 mg) intraop with repeated doses of 0.2 mg/kg (max 15 mg) as indicated. Sugammadex 2-4 mg/kg IV at the end of surgery.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours after surgery.
Monitoring:
1. Bispectral index system
2. TetraGraph neuromuscular transmission monitor
3. ExSpiron respiratory volume monitor in PACU
Rocuronium: After induction of anesthesia and IV placement, administration of rocuronium 0.6 mg/kg (max 50 mg). Administration of additional doses of 0.2 mg/kg (max 15 mg) when TetraGraph indicates a train of four count of 2 or greater.
Sugammadex: Administration of sugammadex 2 mg/kg at the end of surgery if the TetraGraph indicates the train of four count is 2 or greater. Sugammadex 4 mg/kg will be administered if 1) the train of four count is 1, or 2) if the train of four count is 0 and the post tetanic count is at least 1. There is no maximum dose of sugammadex.
|
No Neuromuscular Blockade
Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance of anesthesia
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours.
Device monitoring:
1. Bispectral index system intraop
2. ExSpiron respiratory volume monitor intraop and in PACU
Anesthesia without neuromuscular blockade: Anesthesia without rocuronium or sugammadex
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
|
Overall Study
COMPLETED
|
86
|
86
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Unable to retrieve BIS values for 6 participants.
Baseline characteristics by cohort
| Measure |
Neuromuscular Blockade
n=86 Participants
Rocuronium 0.6 mg/kg IV (max 50 mg) intraop with repeated doses of 0.2 mg/kg (max 15 mg) as indicated. Sugammadex 2-4 mg/kg IV at the end of surgery.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours after surgery.
Monitoring:
1. Bispectral index system
2. TetraGraph neuromuscular transmission monitor
3. ExSpiron respiratory volume monitor in PACU
Rocuronium: After induction of anesthesia and IV placement, administration of rocuronium 0.6 mg/kg (max 50 mg). Administration of additional doses of 0.2 mg/kg (max 15 mg) when TetraGraph indicates a train of four count of 2 or greater.
Sugammadex: Administration of sugammadex 2 mg/kg at the end of surgery if the TetraGraph indicates the train of four count is 2 or greater. Sugammadex 4 mg/kg will be administered if 1) the train of four count is 1, or 2) if the train of four count is 0 and the post tetanic count is at least 1. There is no maximum dose of sugammadex.
|
No Neuromuscular Blockade
n=86 Participants
Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance of anesthesia
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours.
Device monitoring:
1. Bispectral index system intraop
2. ExSpiron respiratory volume monitor intraop and in PACU
Anesthesia without neuromuscular blockade: Anesthesia without rocuronium or sugammadex
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.9 years
STANDARD_DEVIATION 2.9 • n=86 Participants
|
7 years
STANDARD_DEVIATION 3.2 • n=86 Participants
|
6.5 years
STANDARD_DEVIATION 3.1 • n=172 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=86 Participants
|
42 Participants
n=86 Participants
|
81 Participants
n=172 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=86 Participants
|
44 Participants
n=86 Participants
|
91 Participants
n=172 Participants
|
|
Race/Ethnicity, Customized
White
|
56 participants
n=86 Participants
|
54 participants
n=86 Participants
|
110 participants
n=172 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 participants
n=86 Participants
|
17 participants
n=86 Participants
|
38 participants
n=172 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 participants
n=86 Participants
|
15 participants
n=86 Participants
|
24 participants
n=172 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
50 participants
n=86 Participants
|
69 participants
n=86 Participants
|
119 participants
n=172 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
36 participants
n=86 Participants
|
17 participants
n=86 Participants
|
53 participants
n=172 Participants
|
|
Obesity
|
37 Participants
n=86 Participants
|
54 Participants
n=86 Participants
|
91 Participants
n=172 Participants
|
|
Extreme prematurity
|
1 Participants
n=86 Participants
|
1 Participants
n=86 Participants
|
2 Participants
n=172 Participants
|
|
Upper respiratory infection symptoms
|
6 Participants
n=86 Participants
|
4 Participants
n=86 Participants
|
10 Participants
n=172 Participants
|
|
Trisomy 21
|
2 Participants
n=86 Participants
|
1 Participants
n=86 Participants
|
3 Participants
n=172 Participants
|
|
Obstructive sleep apnea severity
No preoperative polysomnogram
|
26 Participants
n=86 Participants
|
29 Participants
n=86 Participants
|
55 Participants
n=172 Participants
|
|
Obstructive sleep apnea severity
Mild obstructive sleep apnea
|
11 Participants
n=86 Participants
|
5 Participants
n=86 Participants
|
16 Participants
n=172 Participants
|
|
Obstructive sleep apnea severity
Moderate obstructive sleep apnea
|
6 Participants
n=86 Participants
|
9 Participants
n=86 Participants
|
15 Participants
n=172 Participants
|
|
Obstructive sleep apnea severity
Severe obstructive sleep apnea
|
43 Participants
n=86 Participants
|
43 Participants
n=86 Participants
|
86 Participants
n=172 Participants
|
|
Intraoperative bispectral index
|
52 index
STANDARD_DEVIATION 7 • n=84 Participants • Unable to retrieve BIS values for 6 participants.
|
48 index
STANDARD_DEVIATION 8 • n=82 Participants • Unable to retrieve BIS values for 6 participants.
|
50 index
STANDARD_DEVIATION 8 • n=166 Participants • Unable to retrieve BIS values for 6 participants.
|
PRIMARY outcome
Timeframe: From surgery start to discharge home, up to 24 hoursContinuous outcome of intravenous morphine milligram equivalents (MME) per kg of body weight
Outcome measures
| Measure |
Neuromuscular Blockade
n=86 Participants
Rocuronium 0.6 mg/kg IV (max 50 mg) intraop with repeated doses of 0.2 mg/kg (max 15 mg) as indicated. Sugammadex 2-4 mg/kg IV at the end of surgery.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours after surgery.
Monitoring:
1. Bispectral index system
2. TetraGraph neuromuscular transmission monitor
3. ExSpiron respiratory volume monitor in PACU
Rocuronium: After induction of anesthesia and IV placement, administration of rocuronium 0.6 mg/kg (max 50 mg). Administration of additional doses of 0.2 mg/kg (max 15 mg) when TetraGraph indicates a train of four count of 2 or greater.
Sugammadex: Administration of sugammadex 2 mg/kg at the end of surgery if the TetraGraph indicates the train of four count is 2 or greater. Sugammadex 4 mg/kg will be administered if 1) the train of four count is 1, or 2) if the train of four count is 0 and the post tetanic count is at least 1. There is no maximum dose of sugammadex.
|
No Neuromuscular Blockade
n=86 Participants
Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance of anesthesia
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours.
Device monitoring:
1. Bispectral index system intraop
2. ExSpiron respiratory volume monitor intraop and in PACU
Anesthesia without neuromuscular blockade: Anesthesia without rocuronium or sugammadex
|
|---|---|---|
|
Cumulative Intra- and Postoperative Opioid Consumption
|
0.209 IV morphine milligram equivalent/kg
Standard Error 0.009
|
0.188 IV morphine milligram equivalent/kg
Standard Error 0.009
|
SECONDARY outcome
Timeframe: From post-anesthesia care unit admission to discharge home, up to 24 hoursPopulation: Postoperative ward respiratory events measured by administration of questionnaires to nursing staff. Number analyzed represents number of participants with questionnaires returned. PACU respiratory events measured by bedside observation by study staff. No participants had outcome measurements missing from the PACU.
Composite binary outcome consisting of 1) airway obstruction or hypoxemia, defined as SpO2 \<90%, requiring any of the following interventions: supplemental oxygen by nasal cannula or simple face mask, noninvasive positive airway pressure, or reintubation; or 2) unanticipated ICU admission.
Outcome measures
| Measure |
Neuromuscular Blockade
n=86 Participants
Rocuronium 0.6 mg/kg IV (max 50 mg) intraop with repeated doses of 0.2 mg/kg (max 15 mg) as indicated. Sugammadex 2-4 mg/kg IV at the end of surgery.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours after surgery.
Monitoring:
1. Bispectral index system
2. TetraGraph neuromuscular transmission monitor
3. ExSpiron respiratory volume monitor in PACU
Rocuronium: After induction of anesthesia and IV placement, administration of rocuronium 0.6 mg/kg (max 50 mg). Administration of additional doses of 0.2 mg/kg (max 15 mg) when TetraGraph indicates a train of four count of 2 or greater.
Sugammadex: Administration of sugammadex 2 mg/kg at the end of surgery if the TetraGraph indicates the train of four count is 2 or greater. Sugammadex 4 mg/kg will be administered if 1) the train of four count is 1, or 2) if the train of four count is 0 and the post tetanic count is at least 1. There is no maximum dose of sugammadex.
|
No Neuromuscular Blockade
n=86 Participants
Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance of anesthesia
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours.
Device monitoring:
1. Bispectral index system intraop
2. ExSpiron respiratory volume monitor intraop and in PACU
Anesthesia without neuromuscular blockade: Anesthesia without rocuronium or sugammadex
|
|---|---|---|
|
Number of Participants With Postoperative Respiratory Events
Respiratory event PACU or ward
|
32 Participants
|
38 Participants
|
|
Number of Participants With Postoperative Respiratory Events
Respiratory event PACU
|
31 Participants
|
37 Participants
|
|
Number of Participants With Postoperative Respiratory Events
Respiratory event ward
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From post-anesthesia care unit admission to transfer to the postoperative ward, up to 8 hoursPopulation: Two patients in the no neuromuscular blockade group were missing respiratory volume monitor data and therefore the measure of low MV events.
Count outcome of distinct episodes of low MV. MV - the product of respiratory rate and tidal volume - was continuously measured by a noninvasive respiratory volume monitor. Low MV events were defined as episodes of MV less than 40 percent predicted - calculated by the monitor based on the patient's body surface area - for at least two minutes. This definition is routinely used by the monitoring system.
Outcome measures
| Measure |
Neuromuscular Blockade
n=86 Participants
Rocuronium 0.6 mg/kg IV (max 50 mg) intraop with repeated doses of 0.2 mg/kg (max 15 mg) as indicated. Sugammadex 2-4 mg/kg IV at the end of surgery.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours after surgery.
Monitoring:
1. Bispectral index system
2. TetraGraph neuromuscular transmission monitor
3. ExSpiron respiratory volume monitor in PACU
Rocuronium: After induction of anesthesia and IV placement, administration of rocuronium 0.6 mg/kg (max 50 mg). Administration of additional doses of 0.2 mg/kg (max 15 mg) when TetraGraph indicates a train of four count of 2 or greater.
Sugammadex: Administration of sugammadex 2 mg/kg at the end of surgery if the TetraGraph indicates the train of four count is 2 or greater. Sugammadex 4 mg/kg will be administered if 1) the train of four count is 1, or 2) if the train of four count is 0 and the post tetanic count is at least 1. There is no maximum dose of sugammadex.
|
No Neuromuscular Blockade
n=84 Participants
Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance of anesthesia
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours.
Device monitoring:
1. Bispectral index system intraop
2. ExSpiron respiratory volume monitor intraop and in PACU
Anesthesia without neuromuscular blockade: Anesthesia without rocuronium or sugammadex
|
|---|---|---|
|
Number of Low Minute Ventilation (MV) Events in the Post-anesthesia Care Unit
|
0 low minute ventilation events
Interval 0.0 to 16.0
|
0 low minute ventilation events
Interval 0.0 to 5.0
|
Adverse Events
Neuromuscular Blockade
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
No Neuromuscular Blockade
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neuromuscular Blockade
n=86 participants at risk
Rocuronium 0.6 mg/kg IV (max 50 mg) intraop with repeated doses of 0.2 mg/kg (max 15 mg) as indicated. Sugammadex 2-4 mg/kg IV at the end of surgery.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours after surgery.
Monitoring:
1. Bispectral index system
2. TetraGraph neuromuscular transmission monitor
3. ExSpiron respiratory volume monitor in PACU
Rocuronium: After induction of anesthesia and IV placement, administration of rocuronium 0.6 mg/kg (max 50 mg). Administration of additional doses of 0.2 mg/kg (max 15 mg) when TetraGraph indicates a train of four count of 2 or greater.
Sugammadex: Administration of sugammadex 2 mg/kg at the end of surgery if the TetraGraph indicates the train of four count is 2 or greater. Sugammadex 4 mg/kg will be administered if 1) the train of four count is 1, or 2) if the train of four count is 0 and the post tetanic count is at least 1. There is no maximum dose of sugammadex.
|
No Neuromuscular Blockade
n=86 participants at risk
Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered.
SOC drugs:
1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
2. Sevoflurane induction and maintenance of anesthesia
3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses).
6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours.
Device monitoring:
1. Bispectral index system intraop
2. ExSpiron respiratory volume monitor intraop and in PACU
Anesthesia without neuromuscular blockade: Anesthesia without rocuronium or sugammadex
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Drug reaction
|
1.2%
1/86 • 24 hours
Adverse events collected through regular investigator assessment.
|
0.00%
0/86 • 24 hours
Adverse events collected through regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Drug effect
|
0.00%
0/86 • 24 hours
Adverse events collected through regular investigator assessment.
|
1.2%
1/86 • 24 hours
Adverse events collected through regular investigator assessment.
|
Additional Information
Dr. Proshad Efune
University of Texas Southwestern Medical Center
Phone: 2144566393
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place