The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA). (OSA)

A Pilot Study to Evaluate if Caffeine Helps Children With Obstructive Sleep Apnea Recover Faster From Anesthesia, and With Less Complications After General Anesthesia for Tonsillectomy and Adenoidectomy.

This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Postoperative Complications; Tonsillectomy; Adenoidectomy
• Intervention / Treatment: Drug: Placebo; Drug: Caffeine

Detailed Description

Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative complications, and require careful monitoring post-operatively.

Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities, we believe that a central element may contribute to OSA.

The aim of this study is to evaluate whether administration of caffeine to children with OSA, scheduled for elective T & A under general anesthesia contributes to a faster recovery, less post-operative complications, and a shorter stay in the PACU, DSU and the hospital.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas, Health Science Center at Houston, Children's Memorial Hermann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children between 2.5-18 years old
• Diagnosed with obstructive sleep apnea
• Undergoing elective tonsillectomy and adenoidectomy

Exclusion Criteria:

• Age below 2.5 or above 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Saline	Drug: Placebo; Children in group two will receive an amount of normal saline equal to Caffeine; Other Names: Saline
Active Comparator: Caffeine; Caffeine benzoate	Drug: Caffeine; Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.	The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.	Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of Post Extubatory Respiratory Adverse Events.	The overall occurance of adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the OR and in the PACU was noted.	Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
Extubation Time.	Time from end of anesthesia until extubation.	Duration from anesthesia end until extubation time.
Awakening Time	A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.	Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.
Post Anesthesia Care Unit (PACU) Duration		Time spent in PACU following surgical procedure prior to discharge home or hospital admission.
Hospital Discharge Time	Children were discharged from the hospital when they reached the hospital discharge criteria: they were awake, had stable vital signs, were breathing adequately, had O2 saturation >95% while breathing room air, were able to swallow fluids, had no or minimal pain, and were able to ambulate without excessive nausea, vomiting, or dizziness.	Total time from end anesthesia to discharge home

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Samia N. Khalil, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: January 4, 2006
• First Submitted That Met QC Criteria: January 4, 2006
• First Posted (Estimate): January 9, 2006

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Recovery; Postoperative Complications; Obstructive Sleep Apnea (OSA); Tonsillectomy and Adenoidectomy (T&A)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Postoperative Complications; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: HSC-MS-03-108