Pediatric Rigid BronchoscopyPhase 4NCT01947114
Remifentanil Use in Pediatric Rigid Bronchoscopy
A Phase 4 study testing Propofol, Ketamine and Remifentanil in people with Pediatric Rigid Bronchoscopy, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: In this study we wanted to compare bolus propofol and ketamine as an adjuvant to remifentanil-based total intravenous anesthesia for pediatric rigid bronchoscopy. Materials and Methods: Forty children under 12 years of age scheduled for rigid bronchoscopy were included. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Pediatric Rigid Bronchoscopy
- What is being tested?
- Propofol, Ketamine and Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2005to Aug 2006
- Phase
- Phase 4
- 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 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who were scheduled to have rigid bronchoscopy for diagnostic purposes (suspected foreign body aspiration, bronchoalveolar lavage)
- Children who were scheduled to have rigid bronchoscopy for therapeutic purposes (removal of foreign bodies and/or mucus plugs)
Who cannot join
- Severe cardiovascular disease
- Cerebral, hepatic or renal dysfunction
- Neuromuscular disease
- Children with predicted difficulty in laryngoscopy and intubation
- Patients requiring prompt interventions for a life-threatening situation (acutely compromised airway with SpO2 values below 70%)
- Patients scheduled for additional interventions or surgery subsequent to rigid bronchoscopy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Faculty of Medicine
Istanbul, 34093
About this study
Official title: Remifentanil-based Total Intravenous Anesthesia for Pediatric Rigid Bronchoscopy: Comparison of Propofol and Ketamine As Adjuvant
Purpose: In this study we wanted to compare bolus propofol and ketamine as an adjuvant to remifentanil-based total intravenous anesthesia for pediatric rigid bronchoscopy.
Materials and Methods: Forty children under 12 years of age scheduled for rigid bronchoscopy were included. After midazolam premedication, remifentanil infusion 1 µg/kg/min was started and patients were randomly allocated to receive either propofol (Group P) or ketamine (Group K) and mivacurium for muscle relaxation. Anesthesia was maintained with remifentanil infusion 1 µg/kg/min and bolus doses of propofol or ketamine. After rigid bronchoscopy remifentanil 0.05 µg/kg/min was maintained until extubation. Hemodynamic parameters, emergence characteristics and adverse events were evaluated.
Read the detailed description
After approval by Institutional Ethics Committee and obtaining informed consent of parents, 40 consecutive children under 12 years who were scheduled to have RB for diagnostic (suspected foreign body aspiration, bronchoalveolar lavage) and/or therapeutic purposes (removal of foreign bodies and/or mucus plugs) were included.
Fasting time before induction of anesthesia was at least 6 hours for solid food and 4 hours for clear liquids. Before admission to the preoperative holding area, a local anesthetic cream was applied to the insertion site and IV catheterization was performed. Midazolam (0.05 mg/kg) was given intravenously just before admission to the operating room. Pulse oximetry (SpO2), ECG and non-invasive blood pressure were monitored. Before induction all children were pre-oxygenated and a crystalloid infusion 10 mg/kg/h was started. Children were randomly allocated to one of two groups according to sealed envelopes. After a second dose of IV midazolam 0.05 mg/kg, remifentanil infusion 1 µg/kg/min was started. During the 1st minute of remifentanil infusion, propofol 2-4 mg/kg, including lidocaine 1 mg/mL for injection pain (Group P) or ketamine 2-3 mg/kg (Group K) was administered. When adequate mask ventilation was ensured, mivacurium 0.15 mg/kg was administered for muscle relaxation and RB was begun at the 4-5th minute of remifentanil infusion. Depth of anesthesia was assessed clinically by hemodynamic parameters (heart rate, blood pressure), movement, coughing, bucking, lacrimation and sweating. Additional doses of propofol (0.5-1 mg/kg) or ketamine (0.25-0.5 mg/kg), with or without mivacurium (0.025-0.05 mg/kg, according to the course of bronchoscopy) were given when inadequate depth of anesthesia was considered. Remifentanil infusion 1 µg/kg/min was maintained throughout the procedure.
Patients were manually ventilated with a 'T' piece connected to the side arm of the rigid bronchoscope. The fresh gas flow was adjusted to 6-10 L/min. In case of major air leakage, oxygen flush valve was used for adequate filling of the reservoir bag while airway pressure limit was adjusted to 20-30 cmH2O.
After bronchoscopy, endotracheal intubation was performed, manually controlled or assisted ventilation with 4-8 cmH2O PEEP and 50% oxygen in air was performed. Tracheal and oral secretions were suctioned as needed and the patients were turned to the lateral decubitus position for recovery. After being placed in the recovery position, no further stimulation was allowed except gentle suctioning of oral secretions and for a smooth extubation remifentanil infusion was decreased to 0.05 µg/kg/min and continued until just before extubation. When patients began to demonstrate emergence from anesthesia by displaying a regular respiratory pattern, facial grimacing or purposeful movement, trachea was extubated. In cases of breath-holding and arterial oxygen desaturation, assisted or controlled mask ventilation was performed. Pure oxygen was administered via the mask in order to maintain SpO2 above 94%.
Noninvasive blood pressure was measured before induction as a baseline value, after induction (just before laryngoscopy) and in 3 minutes of interval during rigid bronchoscopy. Hypotension was defined as a systolic blood pressure lower than 60 mmHg for children under 2 years and 70 mmHg for children 2-12 years old. Hypotension was treated with an increase in IV crystalloid infusion and two consecutive measures of hypotension treated with ephedrine and a decrease in remifentanil infusion. Bradycardia was defined as a heart rate slower than 80 beats/min for infants and 60 beats/min for older children (11) and treated with atropine 0.01 mg/kg.
SpO2 values below 90% were defined as hypoxemia. The severity of hypoxemia was graded as mild (SpO2: 80-89%), moderate (SpO2: 70-79%) or severe (SpO2<70%). Coughing or respiratory effort (diaphragm movement) and limb movement during laryngoscopy and rigid bronchoscopy was graded as mild (minor movement that does not effect surgical comfort), moderate (effect surgical comfort) or severe (the bronchoscope has to be removed or any complication) by the endoscopist. Postoperative severe restlessness and disorientation with purposeless activity were defined as emergence agitation. All adverse events were recorded by an independent observer.
A pilot study was performed with the technique used for the Group P. Power analysis showed that a minimum sample size of 40 patients (20 in each group) was required to detect a 20% change in arterial pressures at a power level of 90% with p<0.05. Categorical variables and hemodynamic parameters were analyzed using Mann-Whitney U Test and repeated-measures Anova respectively. Comparison of the incidence of the outcomes between the two groups was analyzed by a two-tailed Fisher's exact test. Statistical significance was defined as p<0.05.
- Conditions
- Pediatric Rigid Bronchoscopy
- Being tested
- Propofol, Ketamine, Remifentanil
- Keywords
- General anesthesia,, Children,, Rigid Bronchoscopy,, Remifentanil,, Propofol,, Ketamine.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
KetamineDrug
RemifentanilDrug
| Study group | Role | What they receive |
|---|---|---|
| Group Propofol | Active comparator | Not described Receives: Drug: Propofol; Drug: Remifentanil |
| Group Ketamine | Active comparator | Not described Receives: Drug: Ketamine; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic arterial pressure
Noninvasive systolic blood pressure was measured with 3 minutes of interval during rigid bronchoscopy. The duration of rigid bronchoscopy was 10-15 minutes.
Measured: Systolic arterial pressure was assessed before anesthesia induction (baseline), 2 minutes after anesthesia induction, at 1., 3., 6., 9., 12., and 15. minutes of rigid bronchoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startNov 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Rigid BronchoscopyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mefkur Bakan, MD, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947114
- Sponsor's protocol ID
- CTF.08.11.05/31128
- Status last verified
- Sep 2013
- First submitted
- 4 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil-based Total Intravenous Anesthesia for Pediatric Rigid Bronchoscopy: Comparison of Propofol and Ketamine As Adjuvant
- ClinicalTrials.gov ID
- NCT01947114
- Acronym / sponsor ID
- CTF.08.11.05/31128
- Conditions
- Pediatric Rigid Bronchoscopy
- Keywords
- General anesthesia,, Children,, Rigid Bronchoscopy,, Remifentanil,, Propofol,, Ketamine.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 20 Sep 2013 (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.
Purpose: In this study we wanted to compare bolus propofol and ketamine as an adjuvant to remifentanil-based total intravenous anesthesia for pediatric rigid bronchoscopy.
Materials and Methods: Forty children under 12 years of age scheduled for rigid bronchoscopy were included. After midazolam premedication, remifentanil infusion 1 µg/kg/min was started and patients were randomly allocated to receive either propofol (Group P) or ketamine (Group K) and mivacurium for muscle relaxation. Anesthesia was maintained with remifentanil infusion 1 µg/kg/min and bolus doses of propofol or ketamine. After rigid bronchoscopy remifentanil 0.05 µg/kg/min was maintained until extubation. Hemodynamic parameters, emergence characteristics and adverse events were evaluated.
Detailed description
After approval by Institutional Ethics Committee and obtaining informed consent of parents, 40 consecutive children under 12 years who were scheduled to have RB for diagnostic (suspected foreign body aspiration, bronchoalveolar lavage) and/or therapeutic purposes (removal of foreign bodies and/or mucus plugs) were included.
Fasting time before induction of anesthesia was at least 6 hours for solid food and 4 hours for clear liquids. Before admission to the preoperative holding area, a local anesthetic cream was applied to the insertion site and IV catheterization was performed. Midazolam (0.05 mg/kg) was given intravenously just before admission to the operating room. Pulse oximetry (SpO2), ECG and non-invasive blood pressure were monitored. Before induction all children were pre-oxygenated and a crystalloid infusion 10 mg/kg/h was started. Children were randomly allocated to one of two groups according to sealed envelopes. After a second dose of IV midazolam 0.05 mg/kg, remifentanil infusion 1 µg/kg/min was started. During the 1st minute of remifentanil infusion, propofol 2-4 mg/kg, including lidocaine 1 mg/mL for injection pain (Group P) or ketamine 2-3 mg/kg (Group K) was administered. When adequate mask ventilation was ensured, mivacurium 0.15 mg/kg was administered for muscle relaxation and RB was begun at the 4-5th minute of remifentanil infusion. Depth of anesthesia was assessed clinically by hemodynamic parameters (heart rate, blood pressure), movement, coughing, bucking, lacrimation and sweating. Additional doses of propofol (0.5-1 mg/kg) or ketamine (0.25-0.5 mg/kg), with or without mivacurium (0.025-0.05 mg/kg, according to the course of bronchoscopy) were given when inadequate depth of anesthesia was considered. Remifentanil infusion 1 µg/kg/min was maintained throughout the procedure.
Patients were manually ventilated with a 'T' piece connected to the side arm of the rigid bronchoscope. The fresh gas flow was adjusted to 6-10 L/min. In case of major air leakage, oxygen flush valve was used for adequate filling of the reservoir bag while airway pressure limit was adjusted to 20-30 cmH2O.
After bronchoscopy, endotracheal intubation was performed, manually controlled or assisted ventilation with 4-8 cmH2O PEEP and 50% oxygen in air was performed. Tracheal and oral secretions were suctioned as needed and the patients were turned to the lateral decubitus position for recovery. After being placed in the recovery position, no further stimulation was allowed except gentle suctioning of oral secretions and for a smooth extubation remifentanil infusion was decreased to 0.05 µg/kg/min and continued until just before extubation. When patients began to demonstrate emergence from anesthesia by displaying a regular respiratory pattern, facial grimacing or purposeful movement, trachea was extubated. In cases of breath-holding and arterial oxygen desaturation, assisted or controlled mask ventilation was performed. Pure oxygen was administered via the mask in order to maintain SpO2 above 94%.
Noninvasive blood pressure was measured before induction as a baseline value, after induction (just before laryngoscopy) and in 3 minutes of interval during rigid bronchoscopy. Hypotension was defined as a systolic blood pressure lower than 60 mmHg for children under 2 years and 70 mmHg for children 2-12 years old. Hypotension was treated with an increase in IV crystalloid infusion and two consecutive measures of hypotension treated with ephedrine and a decrease in remifentanil infusion. Bradycardia was defined as a heart rate slower than 80 beats/min for infants and 60 beats/min for older children (11) and treated with atropine 0.01 mg/kg.
SpO2 values below 90% were defined as hypoxemia. The severity of hypoxemia was graded as mild (SpO2: 80-89%), moderate (SpO2: 70-79%) or severe (SpO2<70%). Coughing or respiratory effort (diaphragm movement) and limb movement during laryngoscopy and rigid bronchoscopy was graded as mild (minor movement that does not effect surgical comfort), moderate (effect surgical comfort) or severe (the bronchoscope has to be removed or any complication) by the endoscopist. Postoperative severe restlessness and disorientation with purposeless activity were defined as emergence agitation. All adverse events were recorded by an independent observer.
A pilot study was performed with the technique used for the Group P. Power analysis showed that a minimum sample size of 40 patients (20 in each group) was required to detect a 20% change in arterial pressures at a power level of 90% with p<0.05. Categorical variables and hemodynamic parameters were analyzed using Mann-Whitney U Test and repeated-measures Anova respectively. Comparison of the incidence of the outcomes between the two groups was analyzed by a two-tailed Fisher's exact test. Statistical significance was defined as p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Propofol | Active comparator | Drug: Propofol, Drug: Remifentanil |
| Group Ketamine | Active comparator | Drug: Ketamine, Drug: Remifentanil |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children who were scheduled to have rigid bronchoscopy for diagnostic purposes (suspected foreign body aspiration, bronchoalveolar lavage)
- Children who were scheduled to have rigid bronchoscopy for therapeutic purposes (removal of foreign bodies and/or mucus plugs)
Key exclusion criteria (6 listed)
- Severe cardiovascular disease
- Cerebral, hepatic or renal dysfunction
- Neuromuscular disease
- Children with predicted difficulty in laryngoscopy and intubation
- Patients requiring prompt interventions for a life-threatening situation (acutely compromised airway with SpO2 values below 70%)
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 |
|---|---|---|
| Propofol | Drug | Group Propofol |
| Ketamine | Drug | Group Ketamine |
| Remifentanil | Drug | Group Ketamine, Group Propofol |
Primary outcome
Change in systolic arterial pressure
Time frame: Systolic arterial pressure was assessed before anesthesia induction (baseline), 2 minutes after anesthesia induction, at 1., 3., 6., 9., 12., and 15. minutes of rigid bronchoscopy.
Noninvasive systolic blood pressure was measured with 3 minutes of interval during rigid bronchoscopy. The duration of rigid bronchoscopy was 10-15 minutes.
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 20 Sep 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol, Ketamine and Remifentanil in people with Pediatric Rigid Bronchoscopy, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 6 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 20 Sep 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in systolic arterial pressure (time frame: Systolic arterial pressure was assessed before anesthesia induction (baseline), 2 minutes after anesthesia induction, at 1., 3., 6., 9., 12., and 15. minutes of rigid bronchoscopy.). 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 20 Sep 2013.