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ChildrenNCT01235143

Emergence Agitation Between Sevoflurane and Desflurane in Pediatric

A study testing Desflurane and Sevoflurane in people with Children and Urologic Diseases, run by Prince of Songkla University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sevoflurane is the volatile anesthetic agent of choice in pediatric surgery. Nevertheless, sevoflurane anesthesia had the high incidence of emergence delirium compared to halothane and isoflurane.Bortone L et al.reported isoflurane for maintenance decreased incidence of emergence agitation compared to sevoflurane in… Read more about this study

Who is it for?
Ages 1 year to 9 years
Conditions the study is for
Children, Urologic Diseases, Ambulation Difficulty
What is being tested?
Desflurane and Sevoflurane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteThailand
Study dates
May 2010to Aug 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • children aged 1-9 years, with American Society of Anesthesiologists (ASA) physical status I or II ,
  • scheduled to undergo elective ambulatory urologic surgery under general anesthesia combined with regional block

Who cannot join

  • emergency procedures
  • medical contraindication to placement of a caudal block
  • mental retardation
  • developmental delay
  • attention-deficit/hyperactivity disorder
  • psychiatric illness
  • a history of paradoxical excitation with sedatives

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Songklanagarind Hospital

    Hat Yai, Changwat Songkhla, 90110

Other trials in Thailand

About this study

Official title: Comparison the Incidence of Emergence Agitation Between Sevoflurane and Desflurane After Pediatric Urologic Surgery

Sevoflurane is the volatile anesthetic agent of choice in pediatric surgery. Nevertheless, sevoflurane anesthesia had the high incidence of emergence delirium compared to halothane and isoflurane.Bortone L et al.reported isoflurane for maintenance decreased incidence of emergence agitation compared to sevoflurane in unpremedicated preschool children under elective subumbilical surgery (32% versus 52% respectively). Desflurane is the new volatile anesthetic agent which provides faster recovery compared to sevoflurane.Valley et al.reported no significant differences between sevoflurane or desflurane anesthesia in children in term of the serious airway complication such as laryngospasm or desaturation excepted the number of coughing episodes were more frequent in the desflurane compared to sevoflurane (36 versus 18).Mayer J et al. reported sevoflurane had severity of Pediatric Anesthesia Emergence Delirium (PAED) scale higher than desflurane in ear, nose, throat inpatient surgery in children (12(2-20) versus 6(0-15) respectively) with no reported of incidence of emergence agitation between those two. Therefore, the investigators would like to compare the incidence of emergence agitation, recovery profile and respiratory events between desflurane and sevoflurane anesthesia in pediatric ambulatory urologic surgery under general anesthesia and combined with regional anesthesia.

Read the detailed description

After institutional review board (Prince of Songkla University, Songkhla, Thailand) approval and written informed consent from parents, 136 children aged 1-9 years, with American Society of Anesthesiologists (ASA) physical status I or II ,scheduled to undergoing elective ambulatory urologic surgery under general anesthesia combined with regional block , were prospectively enrolled in the study. Children were randomized by a computer-generated program to either sevoflurane group (group s, n =68) or desflurane group (group d, n =68) for maintenance of anesthesia . Exclusion criterion included emergency procedures, medical contraindication to placement of a caudal block, mental retardation, developmental delay, attention-deficit/hyperactivity disorder, psychiatric illness, a history of paradoxical excitation with sedatives. Children did not receive any premedication. Parents were allowed to be present for induction. Children's behavior was assessed at the time of separation from parents by using a separation scale 1-4 (1= excellent [separates easily] , 2= good [not clinging, whimpers ,calm with reassurance] , 3 = fair [not clinging , cried , will not calm or quiet] , 4 = poor [crying , clinging to parent]11 . A separation score of 1 or 2 was considered satisfactory , whereas a score of 3 or 4 was considered unsatisfactory. An induction scale 1-4 was used to assess acceptance of the anesthetic mask ( 1 = excellent [unafraid, co-operate, accepts mask readily], 2 = good [slight fear of mask , easily calmed] , 3 = fair[ moderated fear , not calmed with reassurance] ,4 = poor [terrified , crying ,agitated]11. An induction score of 1 or 2 was considered satisfactory , whereas a score of 3 or 4 was considered unsatisfactory. Then , children received a mask induction with either incremental sevoflurane 2-8% or single breath sevoflurane 8% in a 70 % nitrous oxide and 30% oxygen mixture with a 10 L/min fresh gas flow. After inhalation anesthetic induction , an intravenous cannula were place. Ventilation was controlled by laryngeal mask airway (LMA). After established the airway, children were assigned to receive either sevoflurane or desflurane by adjusting end-tidal concentration to deliver a minimum alveolar anesthetic concentration(MAC) of 1. The nitrous oxide in oxygen concentration was reduced to 66% and total gas flow rate was reduced to 5 LMP . All regional block; penile block, ilioinguinal nerve block and caudal block , were performed by discretion of attending anesthesiologist based on routine practice and type of operation.

Intraoperative analgesics or other sedative drug were not given unless the child's heart rate increase > 20% of baseline after incision or during operation and then fentanyl 0.5-1 mcg/kg intravenously was given to supplement analgesia throughout the operation. At the start of surgical closure, the inhaled anesthetic was discontinued. When the wound closure was completed , the nitrous oxide was discontinued with the oxygen flow rate was increase to 10 LMP. The awake LMA removal was followed by extubation criteria. The children were then transported to the post-anesthetic care unit (PACU). The awakening time defined by the time after discontinued inhaled agent until LMA was removed. Duration of surgery and anesthesia were also recorded. The emergence agitation score was assessed by 3 experienced PACU nurse, blinded to the inhaled anesthetic agents. The emergence agitation score 1-4 and duration of agitation were measured in the PACU (1= awake and calm , cooperative ; 2 = crying, requires consoling ; 3 = irritable/restless , screaming , inconsolable ; 4 = combative ,disoriented, thrashing)11. Children with an agitation score of 3 or 4 were classified agitated. Parent were reunited with their children in the PACU after an initial admission and stabilization phase. The pain score 1-10 using the FLACC under the age of 5 and the Face Pain Scale or the Numeric Rating Scale in older children was assessed by the same PACU nurse. If the children had severely agitated by agitation score > 3 for 5 minutes or pain score ≥ 4, the fentanyl 0.5 mcg/kg was administered intravenously every 10-15 min for treatment of agitation or rescue analgesia. Maximum agitation score and maximum pain score were recorded in the PACU. Duration in PACU stay defined by the time arrived in the PACU until discharge from PACU were also recorded. Intraoperative respiratory adverse events and PACU adverse events were recorded.

Primary objective was to compare the incidence of emergence agitation between sevoflurane anesthesia and desflurane anesthesia in pediatric ambulatory urologic surgery. Secondary objectives were to compare the recovery profile such as awakening time. Duration of PACU stay, and also intraoperative and PACU respiratory adverse events between sevoflurane anesthesia and desflurane anesthesia.

The statistic analysis The sample size calculation by program R 2.8.1 was based on the incidence of sevoflurane induced emergence agitation 52% by Bortone, et al 4 . the investigators calculated a sample size of 62 subjects per treatment arm wound have at least an 80% power to detect desflurane reduced of 50% compared to sevoflurane in the incidence of emergency agitation. The calculation was included the 10% dropout of the study, so 136 children were enrolled in the study.

Date were reported as mean±SD , median (range). Continuous data such as age, weight. duration of surgery, duration of anesthesia, awakening time, onset of agitation , duration of agitation, duration of PACU stay and PACU pain score were analyzed by unpaired Student's test. Categorical data such as gender , ASA physical status, a separation scale, an induction scale, type of operation, type of operation, an emergence agitation scale, intraoperative and PACU adverse events were compared using the Pearson's chi-square test. Incidence of emergence agitation and other adverse events were reported as number and percent (n, %). A P value of 0.05 was considered for statistical significance.

Being tested
Desflurane, Sevoflurane
Keywords
incidence, emergence agitation, sevoflurane, desflurane, ambulatory pediatric surgery
Medical subject headings
Urologic Diseases, Mobility Limitation, Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DesfluraneDrug

    Also called Suprane (desflurane, USP)

    Desflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery

  • SevofluraneDrug

    Also called sevorane

    Sevoflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery

Study groups in NCT01235143
Study groupRoleWhat they receive
desflurane anesthesiaExperimentalmaintenance anesthesia with desflurane
Receives: Drug: Desflurane
sevofluraneActive comparatormaintenance anesthesia with sevoflurane
Receives: Drug: Sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the incidence of emergence agitation

    to compare the incidence of emergence agitation between sevoflurane anesthesia and desflurane anesthesia in pediatric ambulatory urologic surgery.

    Measured: average recovery room period was 120 minutes

Secondary outcomes (1)
  1. the recovery profile

    to compare the recovery profile such as awakening time. Duration of PACU stay, and also intraopertive and PACU respiratory adverse events between sevoflurane anesthesia and desflurane anesthesia.

    Measured: average recovery room period was 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01235143
Sponsor's protocol ID
PSU 136
Status last verified
Oct 2013
First submitted
4 Nov 2010
Last updated
9 Oct 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Desflurane and Sevoflurane in people with Children and Urologic Diseases, run by Prince of Songkla University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the incidence of emergence agitation (time frame: average recovery room period was 120 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.

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