Anesthesia; ReactionNCT02429323
Endotracheal Intubation With Sevoflurane in Surgical Pediatric Patients
A study testing Sevoflurane in people with Anesthesia; Reaction, run by University of Sulaimani.
Trial summary
Aim of the study is to compare the optimal time needed for successful tracheal intubation with immediate 8% sevoflurane and incremental sevoflurane induction in surgical pediatric patients undergoing adenotonsillectomy without using muscle relaxants or opioids Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Anesthesia; Reaction
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Nov 2011
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 2-7 years old American society of anesthesiologists physical status class 1 and 2 scheduled for elective adenotonsillectomy operations
Who cannot join
- Children with extreme weight, suspicion of difficult airway, moved during laryngoscopy, or more than one trial of laryngoscopy needed
About this study
Official title: Endotracheal Intubation With Sevoflurane in Surgical Pediatric Patients: Incremental Versus High Concentration Inhalation Induction
Aim of the study is to compare the optimal time needed for successful tracheal intubation with immediate 8% sevoflurane and incremental sevoflurane induction in surgical pediatric patients undergoing adenotonsillectomy without using muscle relaxants or opioids
Read the detailed description
Investigators studied 100 pediatric surgical patients admitted to Sulaimani Teaching Hospital in the Otorhinolaryngology, Head and Neck Surgical Department, from the first of June 2011 to the first of September 2011, Children aged 2-7 years,both genders, ASA physical statuses І and II (ASA I: a healthy normal patient, while ASA II: a patient with mild systemic disease with no functional limitations) were scheduled for elective adenotonsillectomy operations. They were randomly divided into two equal groups according to the induction method.
Group 1 (G1) using incremental induction with sevoflurane (1-8 %) in 100% O2, the vapor concentration is increased by 1% every few breaths.
Group 2 (G2) high concentration of sevoflurane (8%) in 100% O2 from the beginning of induction.
None of them is given premedication or any other adjunct drugs until successful intubation is done; ventilation was assisted and then controlled when possible. If upper airway obstruction occurred, an oropharyngeal airway was immediately inserted. Attempts were made to obtain venous access before laryngoscopy. All patients monitored with electrocardiography (ECG), noninvasive blood pressure monitoring (NIBP), pulse oximetry, and temperature measurements.
Children with extreme weight, suspicion of difficult airway, moved during laryngoscopy, or more than one trial of laryngoscopy needed were excluded from this study.
The endotracheal tube (ETT) size was selected by using the formula (age/4) + 4.5. Only a single laryngoscopy attempt was allowed. Small, brief movements of extremities occurring after (ETT) placement did not considered as exclusion criteria. Anesthesia was delivered by anesthetic machine (Datex Ohmeda), using an Ayer's T-piece with Jackson Ree's modification system, with a fresh gas flow of 6 L/min through a Sevoflurane vaporizer.
Patients were observed until eyelash reflex disappears, pupils centered and constricted. Jaw relaxation and movements were monitored. Ventilation was controlled till the time of laryngoscopy; the vocal cords were completely visible, orotracheal intubation done with Macintosh laryngoscope blade size 2 by the same anesthetist for all the patients. The time from induction until successful tracheal intubation is recorded.
- Conditions
- Anesthesia; Reaction
- Being tested
- Sevoflurane
- Keywords
- induction, pediatrics, sevoflurane, intubation time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called sevorane abbott
use of 8% sevoflurane in compared to incremental dose increased each few breaths from 1% to 8%
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane concentration 8% | Active comparator | sevoflurane concentration 8% from the start Receives: Drug: Sevoflurane |
| incremental sevoflurane (1-8%) | Active comparator | incremental increase of the concentration each few breaths from 1% to 8% Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction to intubation time in seconds
effect of high concentration of sevoflurane on shortening the induction to intubation time
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir M. Boujan, University of Sulaimani
- Investigators
- Amir M. Boujan, board, Study director, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429323
- Sponsor's protocol ID
- 8
- Status last verified
- Apr 2015
- First submitted
- 18 Apr 2015
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
James Duke, Pediatric Anesthesia, Anesthesia Secrets, Philadelphia 2011, Fourth Edition, Chapter 57, Page 396.
Johr M. Anaesthesia for tonsillectomy. Curr Opin Anaesthesiol. 2006 Jun;19(3):260-1. doi: 10.1097/01.aco.0000192789.78139.54. No abstract available.
PubMed 16735808Chawathe M, Zatman T, Hall JE, Gildersleve C, Jones RM, Wilkes AR, Aguilera IM, Armstrong TS. Sevoflurane (12% and 8%) inhalational induction in children. Paediatr Anaesth. 2005 Jun;15(6):470-5. doi: 10.1111/j.1460-9592.2005.01478.x.
PubMed 15910347Inomata S, Yamashita S, Toyooka H, Yaguchi Y, Taguchi M, Sato S. Anaesthetic induction time for tracheal intubation using sevoflurane or halothane in children. Anaesthesia. 1998 May;53(5):440-5. doi: 10.1046/j.1365-2044.1998.00338.x.
PubMed 9659016Politis GD, Tobin JR, Morell RC, James RL, Cantwell MF. Tracheal intubation of healthy pediatric patients without muscle relaxant: a survey of technique utilization and perceptions of safety. Anesth Analg. 1999 Apr;88(4):737-41. doi: 10.1097/00000539-199904000-00009.
PubMed 10195514Redhu S, Jalwal GK, Saxena M, Shrivastava OP. A Comparative Study of Induction, Maintenance and Recovery Characteristics of Sevoflurane and Halothane Anaesthesia in Pediatric Patients (6 months to 6 years). J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):484-7.
PubMed 21547175Blair JM, Hill DA, Bali IM, Fee JP. Tracheal intubating conditions after induction with sevoflurane 8% in children. A comparison with two intravenous techniques. Anaesthesia. 2000 Aug;55(8):774-8. doi: 10.1046/j.1365-2044.2000.01470.x.
PubMed 10947692Fenlon S, Pearce A. Sevoflurane induction and difficult airway management. Anaesthesia. 1997 Mar;52(3):285-6. No abstract available.
PubMed 9124682Epstein RH, Stein AL, Marr AT, Lessin JB. High concentration versus incremental induction of anesthesia with sevoflurane in children: a comparison of induction times, vital signs, and complications. J Clin Anesth. 1998 Feb;10(1):41-5. doi: 10.1016/s0952-8180(97)00218-3.
PubMed 9526937Baum VC, Yemen TA, Baum LD. Immediate 8% sevoflurane induction in children: a comparison with incremental sevoflurane and incremental halothane. Anesth Analg. 1997 Aug;85(2):313-6. doi: 10.1097/00000539-199708000-00013.
PubMed 9249106Dubois MC, Piat V, Constant I, Lamblin O, Murat I. Comparison of three techniques for induction of anaesthesia with sevoflurane in children. Paediatr Anaesth. 1999;9(1):19-23.
PubMed 10712710
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Intubation With Sevoflurane in Surgical Pediatric Patients: Incremental Versus High Concentration Inhalation Induction
- ClinicalTrials.gov ID
- NCT02429323
- Acronym / sponsor ID
- 8
- Conditions
- Anesthesia; Reaction
- Keywords
- induction, pediatrics, sevoflurane, intubation time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to compare the optimal time needed for successful tracheal intubation with immediate 8% sevoflurane and incremental sevoflurane induction in surgical pediatric patients undergoing adenotonsillectomy without using muscle relaxants or opioids
Detailed description
Investigators studied 100 pediatric surgical patients admitted to Sulaimani Teaching Hospital in the Otorhinolaryngology, Head and Neck Surgical Department, from the first of June 2011 to the first of September 2011, Children aged 2-7 years,both genders, ASA physical statuses І and II (ASA I: a healthy normal patient, while ASA II: a patient with mild systemic disease with no functional limitations) were scheduled for elective adenotonsillectomy operations. They were randomly divided into two equal groups according to the induction method.
Group 1 (G1) using incremental induction with sevoflurane (1-8 %) in 100% O2, the vapor concentration is increased by 1% every few breaths.
Group 2 (G2) high concentration of sevoflurane (8%) in 100% O2 from the beginning of induction.
None of them is given premedication or any other adjunct drugs until successful intubation is done; ventilation was assisted and then controlled when possible. If upper airway obstruction occurred, an oropharyngeal airway was immediately inserted. Attempts were made to obtain venous access before laryngoscopy. All patients monitored with electrocardiography (ECG), noninvasive blood pressure monitoring (NIBP), pulse oximetry, and temperature measurements.
Children with extreme weight, suspicion of difficult airway, moved during laryngoscopy, or more than one trial of laryngoscopy needed were excluded from this study.
The endotracheal tube (ETT) size was selected by using the formula (age/4) + 4.5. Only a single laryngoscopy attempt was allowed. Small, brief movements of extremities occurring after (ETT) placement did not considered as exclusion criteria. Anesthesia was delivered by anesthetic machine (Datex Ohmeda), using an Ayer's T-piece with Jackson Ree's modification system, with a fresh gas flow of 6 L/min through a Sevoflurane vaporizer.
Patients were observed until eyelash reflex disappears, pupils centered and constricted. Jaw relaxation and movements were monitored. Ventilation was controlled till the time of laryngoscopy; the vocal cords were completely visible, orotracheal intubation done with Macintosh laryngoscope blade size 2 by the same anesthetist for all the patients. The time from induction until successful tracheal intubation is recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane concentration 8% | Active comparator | Drug: Sevofluranesevoflurane concentration 8% from the start |
| incremental sevoflurane (1-8%) | Active comparator | Drug: Sevofluraneincremental increase of the concentration each few breaths from 1% to 8% |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 2-7 years old American society of anesthesiologists physical status class 1 and 2 scheduled for elective adenotonsillectomy operations
Key exclusion criteria (1 listed)
- Children with extreme weight, suspicion of difficult airway, moved during laryngoscopy, or more than one trial of laryngoscopy needed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: sevorane abbottuse of 8% sevoflurane in compared to incremental dose increased each few breaths from 1% to 8% | Drug | incremental sevoflurane (1-8%), sevoflurane concentration 8% |
Primary outcome
induction to intubation time in seconds
Time frame: during the surgery
effect of high concentration of sevoflurane on shortening the induction to intubation time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- BackgroundJames Duke, Pediatric Anesthesia, Anesthesia Secrets, Philadelphia 2011, Fourth Edition, Chapter 57, Page 396.
- Background: PubMed 16735808Johr M. Anaesthesia for tonsillectomy. Curr Opin Anaesthesiol. 2006 Jun;19(3):260-1. doi: 10.1097/01.aco.0000192789.78139.54. No abstract available.
- Background: PubMed 15910347Chawathe M, Zatman T, Hall JE, Gildersleve C, Jones RM, Wilkes AR, Aguilera IM, Armstrong TS. Sevoflurane (12% and 8%) inhalational induction in children. Paediatr Anaesth. 2005 Jun;15(6):470-5. doi: 10.1111/j.1460-9592.2005.01478.x.
- Background: PubMed 9659016Inomata S, Yamashita S, Toyooka H, Yaguchi Y, Taguchi M, Sato S. Anaesthetic induction time for tracheal intubation using sevoflurane or halothane in children. Anaesthesia. 1998 May;53(5):440-5. doi: 10.1046/j.1365-2044.1998.00338.x.
- Background: PubMed 10195514Politis GD, Tobin JR, Morell RC, James RL, Cantwell MF. Tracheal intubation of healthy pediatric patients without muscle relaxant: a survey of technique utilization and perceptions of safety. Anesth Analg. 1999 Apr;88(4):737-41. doi: 10.1097/00000539-199904000-00009.
- Background: PubMed 21547175Redhu S, Jalwal GK, Saxena M, Shrivastava OP. A Comparative Study of Induction, Maintenance and Recovery Characteristics of Sevoflurane and Halothane Anaesthesia in Pediatric Patients (6 months to 6 years). J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):484-7.
- Background: PubMed 10947692Blair JM, Hill DA, Bali IM, Fee JP. Tracheal intubating conditions after induction with sevoflurane 8% in children. A comparison with two intravenous techniques. Anaesthesia. 2000 Aug;55(8):774-8. doi: 10.1046/j.1365-2044.2000.01470.x.
- Background: PubMed 9124682Fenlon S, Pearce A. Sevoflurane induction and difficult airway management. Anaesthesia. 1997 Mar;52(3):285-6. No abstract available.
- Background: PubMed 9526937Epstein RH, Stein AL, Marr AT, Lessin JB. High concentration versus incremental induction of anesthesia with sevoflurane in children: a comparison of induction times, vital signs, and complications. J Clin Anesth. 1998 Feb;10(1):41-5. doi: 10.1016/s0952-8180(97)00218-3.
- Background: PubMed 9249106Baum VC, Yemen TA, Baum LD. Immediate 8% sevoflurane induction in children: a comparison with incremental sevoflurane and incremental halothane. Anesth Analg. 1997 Aug;85(2):313-6. doi: 10.1097/00000539-199708000-00013.
- Background: PubMed 10712710Dubois MC, Piat V, Constant I, Lamblin O, Murat I. Comparison of three techniques for induction of anaesthesia with sevoflurane in children. Paediatr Anaesth. 1999;9(1):19-23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir M. Boujan, board study director
School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane in people with Anesthesia; Reaction, run by University of Sulaimani.
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 1 inclusion and 1 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
induction to intubation time in seconds (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429323, which also lists 11 linked publications.
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 29 Apr 2015.