The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation

Obstructive Sleep Apnea Clinical Trial

Official title:

Does Dexmedetomidine Decrease the Incidence of Untoward Airway Events After Deep or Awake Extubation in Patients Undergoing Adenotonsillectomy With or Without Myringotomy and Tube Placement?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02162433
• Other study ID #: 14-019H
• Status: Terminated
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: April 23, 2018

Study information

• Verified date: April 2020
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aim to investigate the effect of dexmedetomidine on the perioperative respiratory complications in this patient population undergoing both awake and deep tracheal extubation.

Description:

We propose a prospective double-blinded randomized controlled trial. 336 pediatric patients presenting to Massachusetts Eye and Ear Infirmary (MEEI) for adenotonsillectomy who are eligible for the study based on inclusion and exclusion criteria will be recruited. A Clinical Pharmacy specialist, will be in charge of preparing the dexmedetomidine and placebo doses and will randomize the patients to four equally numbered groups. The anesthesiologist will receive the assignment for the extubation method in a sealed envelope from the Clinical Pharmacy specialist. Multiple parameters will be recorded in perioperative period to quantify perioperative adverse respiratory events.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: April 23, 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

Inclusion Criteria:

• Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty

• ASA 1 & 2

Exclusion Criteria:

• Known allergy or hypersensitivity reaction to dexmedetomidine

• Organ dysfunction (renal/hepatic failure or leukemia)

• Cardiac disease (congenital or acquired)

• Airway or thoracic malformation

• Cerebral palsy

• Hypotonia

• Need for premedication

• Current/recent upper respiratory infection (within four weeks prior to the surgery)

• Asthma

• Allergy or intolerance to clonidine

• Non-English speaking parents/patients.

Related Conditions & MeSH terms

• Adenoiditis
• Adenotonsillar Hypertrophy
• Hypertrophy
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Tonsillitis

Intervention

Drug:
• Normal Saline
to arms 2,4. Serves as the placebo.
• Dexmedetomidine
to arms 1,3

Locations

Country	Name	City	State
United States	MEEI	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Respiratory Complications	Number of patients exhibiting any of the following outcomes: desaturation to less than 95% for more than 10 seconds; breath holding; complete or partial laryngospasm; bronchospasm; croup; number of episodes of persistent cough (three or more consecutive coughs); negative pressure pulmonary edema; stridor.	24 hours
Secondary	Number of Participants With Emergence Agitation	Number of patients with an incidence of emergence agitation post-surgery defined by the Pediatric Anesthesia Emergence Delirium (PAED) scale of >10.; Emergence agitation is characterized by non-purposeful movement, restlessness, thrashing, incoherence, inconsolability, and unresponsiveness. The PAED is a scale used to assess emergence agitation in our patient population. It's minimum value is zero and maximum value is 20, with 0 being no emergence agitation and 20 being the most agitated state.	24 hours
Secondary	Number of Participants With Postoperative Nausea and Vomiting (PONV)	Number of patients who experienced postoperative nausea and vomiting (PONV) as noted by the parental questionnaire administered 24 hours after the patient is discharged.	24 hrs
Secondary	Average Time From End of Surgery to Leaving the Operating Room		24 hours
Secondary	The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)		24 hrs
Secondary	Number of Participants Needing Follow-up Pain Medication	24-hour postoperative pain medication requirement assessed by a parental questionnaire administered 24 hours after discharge. The parents are asked whether their child took any pain medication within the last 24 hours since the surgery.	24 hours
Secondary	Number of Patients With Unplanned Hospital Admission	Any unplanned hospital admission due to perioperative respiratory adverse events.	24 hours