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No neuromuscular blockade for Tonsillectomy

Phase 4

Recruiting

Led By Proshad Efune, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children 2-12 years of age having tonsillectomy with or without adenoidectomy at Children's main Dallas campus

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from surgery start to discharge home, up to 24 hours

Awards & highlights

Study Summary

This trial is comparing two different approaches to anesthesia for high-risk children undergoing adenotonsillectomy surgery. One approach includes muscle relaxation and reversal of the relaxation at the end of surgery, while the

Who is the study for?

This trial is for high-risk children needing adenotonsillectomy surgery. It's designed to see if using muscle relaxants during anesthesia affects pain medication needs or breathing after surgery. Kids will be monitored closely during and after the procedure.Check my eligibility

What is being tested?

The study compares two types of general anesthesia: one with muscle relaxation (using Rocuronium) and its reversal at the end (with Sugammadex), versus anesthesia without muscle relaxation, focusing on post-surgery opioid use and breathing issues.See study design

What are the potential side effects?

Possible side effects may include reactions to Rocuronium or Sugammadex, such as allergic responses, changes in heart rate or blood pressure, nausea, headache, or residual muscle weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child, aged 2-12, is having a tonsil removal surgery at Children's Dallas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from surgery start to discharge home, up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from surgery start to discharge home, up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgery start to discharge home, up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cumulative intra- and postoperative opioid consumption

Secondary outcome measures

Number of low minute ventilation (MV) events in the post-anesthesia care unit

Number of participants with postoperative respiratory events

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: No neuromuscular blockadeExperimental Treatment1 Intervention

Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered. SOC drugs: Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery. Sevoflurane induction and maintenance of anesthesia Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop 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). Ondansetron 0.1 mg/kg (max 4 mg) IV intraop 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: Bispectral index system intraop ExSpiron respiratory volume monitor intraop and in PACU

Group II: Neuromuscular blockadeActive Control2 Interventions

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: Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery. Sevoflurane induction and maintenance of anesthesia Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop 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). Ondansetron 0.1 mg/kg (max 4 mg) IV intraop 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: Bispectral index system intraop TetraGraph neuromuscular transmission monitor intraop ExSpiron respiratory volume monitor intraop and in PACU

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,563 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,974 Total Patients Enrolled

1 Trials studying Tonsillectomy

90 Patients Enrolled for Tonsillectomy

Proshad Efune, MDPrincipal InvestigatorUT Southwestern

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA have any approved neuromuscular blockade alternatives?

"As this trial falls under Phase 4, indicating that the treatment has already received approval, our team at Power rates the safety of No neuromuscular blockade as a 3 on a scale from 1 to 3."

Answered by AI

Is this medical study actively seeking participants at the moment?

"According to the information provided on clinicaltrials.gov, this specific trial is not currently open for patient enrollment. The initial posting of this study was made on March 1st, 2024 and it was last updated on January 24th, 2024. However, there are currently ten other ongoing studies actively seeking participants at this time."

Answered by AI

Are individuals who are 18 years and older eligible to participate in the patient recruitment for this clinical trial?

"To be eligible for this trial, individuals must fall within the age range of 2 to 12 years old. Notably, there are a total of 8 trials available specifically for participants under the age of 18, while there are 6 trials catering to those over the age of 65."

Answered by AI

Recent research and studies

Otolaryngology–Head and Neck SurgeryJournal

Clinical Practice Guideline: Tonsillectomy in Children (update)

Mitchell, Ron B., Sanford M. Archer, Stacey L. Ishman, Richard M. Rosenfeld, Sarah Coles, Sandra A. Finestone, Norman R. Friedman, et al.. 2019. “Clinical Practice Guideline: Tonsillectomy in Children (update)”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1177/0194599818801757.

clinicaltrials.govStudy

Muscle Relaxation for Pediatric Adenotonsillectomy

Proshad Efune, MD 2024. "Muscle Relaxation for Pediatric Adenotonsillectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06225466.

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