Sevoflurane/Dexmedetomidine vs. Isoflurane for Emergence Delirium

Overseen By Molly Herr, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Severe developmental delay, TIVA, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to measure the incidences of pediatric emergence delirium between the group receiving Isoflurane and the group receiving Sevoflurane plus intravenous push dexmedetomidine.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the drug Isoflurane in preventing emergence delirium?

The research suggests that using dexmedetomidine with sevoflurane can reduce the incidence of emergence delirium compared to using sevoflurane alone. This implies that combining different anesthetics, like Isoflurane, with dexmedetomidine might also help in managing emergence delirium. ^{1 2 3 4 5}

Is Sevoflurane/Dexmedetomidine vs. Isoflurane safe for humans?

Sevoflurane and isoflurane are both used as anesthetics and have been studied for their safety in humans. Sevoflurane is known for its fast onset and recovery, but it can contribute to emergence delirium (confusion after waking from anesthesia). Studies have shown that using dexmedetomidine with sevoflurane can reduce the risk of this delirium, suggesting a safety benefit in managing this side effect. ^{2 3 6 7 8}

How does the drug Sevoflurane/Dexmedetomidine differ from other drugs for emergence delirium?

Sevoflurane, when combined with dexmedetomidine, may help reduce the incidence of emergence delirium compared to using sevoflurane alone. Sevoflurane is known for its fast onset and recovery, while dexmedetomidine can act as an adjuvant (helper) to enhance its effects and potentially prevent delirium. ^{1 2 3 6 9}

Research Team

Lindsay Warner, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for children who are undergoing surgery and need anesthesia. It's designed to see if one type of anesthesia can reduce confusion or delirium when they wake up after the operation. Specific details about who can join are not provided here.

Inclusion Criteria

I will have an IV and a breathing tube for my procedure.

I am between 2 and 7 years old.

My treatment can be done as an outpatient or with a hospital stay.

Exclusion Criteria

Previous history of severe emergence delirium documented by a provider (via interventions or explicitly stated)

I have severe developmental delays and cannot interact as required.

My surgery will use total intravenous anesthesia (TIVA).

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Isoflurane or Sevoflurane plus intravenous push dexmedetomidine during anesthesia

Single session

1 visit (in-person)

Recovery

Participants are monitored in the Post Anesthesia Care Unit (PACU) for emergence delirium and length of stay

0-4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Isoflurane (Anesthetic)
• Sevoflurane (Anesthetic)

Trial Overview The study compares two anesthetic approaches: Isoflurane alone versus Sevoflurane combined with a medication called dexmedetomidine. The goal is to see which method better prevents emergence delirium, a state of confusion that sometimes occurs in kids as they recover from anesthesia.

Participant Groups

Group I: Sevoflurane group Active Control 1 Intervention

Group II: Isoflurane group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

In a study of 145 pediatric patients aged 3-10 undergoing anesthesia with sevoflurane, 19.3% experienced emergence delirium, which lasted an average of 6.9 minutes and often required pharmacological intervention.

Younger age and higher preoperative anxiety levels were significant risk factors for emergence delirium, with younger children being 3.3 times more likely and those with moderate to severe anxiety being 5.6 times more likely to experience this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The incidence of emergence delirium and risk factors following sevoflurane use in pediatric patients for day case surgery, Kingston, Jamaica]. Gooden, R., Tennant, I., James, B., et al.[2014]

In a systematic review of 66 studies involving 5257 pediatric patients, the use of dexmedetomidine with sevoflurane significantly reduced the incidence of emergence delirium compared to sevoflurane alone (9.1% vs. 40%).

However, while dexmedetomidine reduced emergence delirium, it was associated with a higher incidence of postoperative nausea and vomiting (PONV), indicating that clinical decisions should weigh the risks of both outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine vs. total intravenous anaesthesia in paediatric emergence delirium: A network meta-analysis. Petre, MA., Levin, DN., Englesakis, M., et al.[2021]

In a study of 90 pediatric patients undergoing dental surgery with sevoflurane anesthesia, intranasal dexmedetomidine significantly reduced the incidence of emergence delirium (ED) compared to a control group, with a notable effect at dosages of 1 μg/kg and 2 μg/kg.

The higher dosage of 2 μg/kg not only decreased severe ED but also improved the children's acceptance of mask induction and their tolerance during separation from parents, indicating its potential for enhancing the overall anesthesia experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Intranasal Dexmedetomidine on Emergence Delirium Prevention in Pediatric Ambulatory Dental Rehabilitation Under General Anesthesia: A Randomized Clinical Trial. He, H., Cui, Q., Chen, H., et al.[2023]

The study found that the incidence of emergence delirium in adult patients after general anesthesia with sevoflurane is 11.8%, indicating that this condition is more common in adults than previously reported.

Significant risk factors for emergence delirium included being over 65 years old, undergoing emergency surgery, being of African ethnicity, having longer surgery durations, and the number of intubation attempts, suggesting that these factors should be monitored to reduce the risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Emergence delirium following sevoflurane anesthesia in adults: prospective observational study]. Ramroop, R., Hariharan, S., Chen, D.[2022]

In a study of 46 children undergoing elective ear-nose-throat surgery, there was no significant difference in the incidence of emergence delirium (ED) between those receiving sevoflurane and those receiving desflurane for anesthesia maintenance.

Both anesthetics showed similar safety profiles, with no increase in adverse events like nausea or vomiting, suggesting that desflurane can be safely used in this pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing incidence of emergence delirium between sevoflurane and desflurane in children following routine otolaryngology procedures. Driscoll, JN., Bender, BM., Archilla, CA., et al.[2019]

In a study of 88 children aged 2-6 undergoing cataract surgery, both desflurane and sevoflurane anesthesia resulted in similar rates of postoperative emergence delirium (ED), with 18.18% in the sevoflurane group and 20.45% in the desflurane group, indicating that both anesthetics are comparably safe in this regard.

Desflurane allowed for faster emergence from anesthesia compared to sevoflurane, suggesting it may be more efficient for recovery, although both drugs had similar effects on ED as measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative emergence delirium in pediatric patients undergoing cataract surgery--a comparison of desflurane and sevoflurane. Sethi, S., Ghai, B., Ram, J., et al.[2022]

In a study of 117 children recovering from general anesthesia, the Pediatric Anesthesia Emergence Delirium (PAED) scale identified emergence delirium (ED) in 32% of cases, while the Watcha and Cravero scales identified 26% and 35%, respectively, indicating variability in detection rates among the scales.

The PAED scale showed improved sensitivity and specificity for detecting ED when a score greater than 12 was used, while the Watcha scale was noted for its simplicity and potentially higher overall sensitivity and specificity in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of emergence delirium scales following general anesthesia in children. Bajwa, SA., Costi, D., Cyna, AM.[2022]

In a study involving 143 adult patients, sevoflurane was found to allow for a quicker recovery from general anesthesia compared to isoflurane, with shorter times for extubation, eye opening, and command response.

Both sevoflurane and isoflurane demonstrated similar safety profiles, as there were no significant differences in renal and hepatic function before and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance and recovery characteristics of sevoflurane anaesthesia in adult patients. A multicenter, randomized comparison with isoflurane. Ranieri, R., Martinelli, G., Pagani, I., et al.[2018]

In a study of 60 patients undergoing intracranial surgery, sevoflurane (SEVO) was found to provide a significantly faster recovery time compared to isoflurane (ISO), with patients emerging from anesthesia and responding to commands more quickly.

The faster recovery with SEVO, demonstrated by earlier Glasgow coma scale scores, is clinically important for timely neurological assessments in neurosurgical patients, especially after long-duration surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sevoflurane provides faster recovery and postoperative neurological assessment than isoflurane in long-duration neurosurgical cases. Gauthier, A., Girard, F., Boudreault, D., et al.[2019]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[The incidence of emergence delirium and risk factors following sevoflurane use in pediatric patients for day case surgery, Kingston, Jamaica]. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Dexmedetomidine vs. total intravenous anaesthesia in paediatric emergence delirium: A network meta-analysis. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

The Effect of Intranasal Dexmedetomidine on Emergence Delirium Prevention in Pediatric Ambulatory Dental Rehabilitation Under General Anesthesia: A Randomized Clinical Trial. [2023]

4. Brazil pubmed.ncbi.nlm.nih.gov

[Emergence delirium following sevoflurane anesthesia in adults: prospective observational study]. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Comparing incidence of emergence delirium between sevoflurane and desflurane in children following routine otolaryngology procedures. [2019]

6. France pubmed.ncbi.nlm.nih.gov

Postoperative emergence delirium in pediatric patients undergoing cataract surgery--a comparison of desflurane and sevoflurane. [2022]

7. France pubmed.ncbi.nlm.nih.gov

A comparison of emergence delirium scales following general anesthesia in children. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Maintenance and recovery characteristics of sevoflurane anaesthesia in adult patients. A multicenter, randomized comparison with isoflurane. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Sevoflurane provides faster recovery and postoperative neurological assessment than isoflurane in long-duration neurosurgical cases. [2019]