Complication of AnesthesiaPhase 2/3NCT01958138
Isoflurane Versus Propofol for Removal of LMA in Children
A Phase 2/3 study testing comparison of group-I (low dose propofol with isoflurane) in people with Complication of Anesthesia, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The study will be done in paediatric patients by comparing two different techniques of Laryngeal Mask Airway (LMA) removal under deep anesthetic plane. The both study techniques will be compared for safe LMA removal on the basis of adverse airway events and emergence time duration and recovery room stay timing. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Complication of Anesthesia
- What is being tested?
- comparison of group-I (low dose propofol with isoflurane)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2012to Nov 2013
- Phase
- Phase 2/3
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- American Society of Anesthesiologist class-I \& II patients.
- mallampatis class I \& II.
- Age from 2 years to 10 years.
- Elective surgical patients for below umbilical general surgical procedures.
Who cannot join
- Congenital disorders
- Airway or facial abnormalities
- Reactive airway disease/asthma
- Anticipated difficult airway
- History of Upper respiratory tract infection in last 3 weeks
- History of gastroesophageal reflux disorders
- Known allergic to isoflurane and propofol
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Operating room at Aga Khan University Hospital
Karachi, Sindh, 3500
About this study
Official title: Isoflurane Versus Combination Of Propofol With Isoflurane For Removal Of Laryngeal Mask Airway In Children
The study will be done in paediatric patients by comparing two different techniques of Laryngeal Mask Airway (LMA) removal under deep anesthetic plane.
The both study techniques will be compared for safe LMA removal on the basis of adverse airway events and emergence time duration and recovery room stay timing.
Read the detailed description
- Study will be start after confirming the approval of institutional ethical review committee and after fulfilling the study inclusion criteria. The detailed study protocol will be explain to the parent/guardian and written \& informed consent will be taking on his/her will.
- Inclusion Criteria
- Age between 2 to 10 years,
- American Society of Anaesthesiologists (ASA) physical status I \& II,
- Patient is not contraindicated to Laryngeal Mask Airway insertion,
- Elective below umbilical general surgical procedures
- patient is planned for general anesthesia with spontaneous breathing.
- Fifty patients will participate in both study groups.
- All patients will be premedicated with oral midazolam 0.3mg/kg, 45 to 60 minutes prior to induction.
- After arrival of patients in operating room, routine anesthesia monitoring will be applied and baseline blood pressure, heart rate, respiratory rate and oxygen saturation will be recorded.
- Patient will be induced with anesthetic induction inhalational agent (sleeping drug) sevoflurane 8% with oxygen by pediatric anesthesia circle system. The sevoflurane concentration will be adjusted to 3% to 4% once the adequate depth of anesthesia achieved, as evident by jaw relaxation and tolerance of an oral airway.
- The LMA will be placed after the insertion of intravenous line.
- The LMA size will be determined as per manufacturer's recommendation; which suggest 1.5 LMA size for 5-10 kg, size 2 for 10-20 kg and size 2.5 for 20-30 kg.
- The anesthesia will be maintained with isoflurane in 60% nitrous oxide and 40% oxygen. Patients will be ventilated by spontaneous mode by 'Mapleson F anesthesia circuit' and for above 25 Kg patient, the circle system will be used.
- Caudal analgesia was standardised in both study groups.
- Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I.
The group-II LMA will removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen. In both groups; LMA will be removed with inflated cuff, throat was suctioned and patients were turned into lateral recovery position.
Isoflurane and nitrous oxide were turned off and 100% oxygen supplemented till the patient had regained consciousness. All participants were transported to Post Anesthesia Care Unit (PACU) once ensured airway patency and peripheral oxygen saturation (Sp02) greater than 93% on room air. Children were allowed to wake up effortlessly in PACU at oxygen 5 litters/minutes via Hudson mask.
- The following study variables will be recorded;
- Emergence time ( patient awakening time),
- Duration of recovery room stay (Post anesthesia care unit),
- Smooth Laryngeal Mask Airway removal will be assessed by
- Cough,
- Hypersalivation,
- 02 desaturation < 90%,
- Teeth clenching,
- Airway obstruction requiring jaw support,
- Laryngospasm,
- Bronchospasm,
- Retching,
- Vomiting,
- Confounding variables will be assessed like;
- Patients demographics,
- Duration of surgery,
- Duration of anesthesia,
- Type of surgery,
- Mode of analgesia
- Number of Laryngeal Mask Airway insertion attempts:
- Conditions
- Complication of Anesthesia
- Being tested
- comparison of group-I (low dose propofol with isoflurane)
- Keywords
- Laryngeal Mask Airway, Propofol, Isoflurane, Pediatric patients, Emergence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of group-I (low dose propofol with isoflurane)Drug
Also called group-II (alone isoflurane MAC 1.2%)
Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I. The group-II LMA will be removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen
| Study group | Role | What they receive |
|---|---|---|
| propofol with Isoflurane | Experimental | Propofol with Isoflurane, Group-I is the intervention arm with combination of two drugs such as low dose propofol and Isoflurane MAC awake. Receives: Drug: comparison of group-I (low dose propofol with isoflurane) |
| alone isoflurane | Active comparator | The group-II is the control arm of study by using the only Isoflurane 1.2 MAC Receives: Drug: comparison of group-I (low dose propofol with isoflurane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence airway complications
Smooth LMA removal will be assessed by adverse airway events like; coughing, bucking, hypersalivation, O2 desaturation (Sp02<90%), airway obstruction (noisy or stridor breathing) requiring jaw support, laryngospasm, bronchospasm, retching and vomiting, time duration from LMA removal up to 15 minutes.
Measured: 15 minutes of continuous monitoring and time frame was started from the LMA removal
Emergence time duration
Impact on emergence time duration because of intervention such as delayed awakening or responding
Measured: 15 minutes of continuous monitoring and time frame was started from the LMA removal
Post anaesthesia care unit stay time duration
Impact of intervention on post anaesthesia care unit admission to discharge time duration
Measured: 0-45 minutes of continuous monitoring and time frame was started from the PACU admission to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Complication of AnesthesiaStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dileep Kumar, Aga Khan University
- Investigators
- dileep kumar, FCPS, Principal investigator, Aga Khan University Hospital Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958138
- Sponsor's protocol ID
- 1995-Ane-ERC-11
- Status last verified
- Feb 2021
- First submitted
- 19 Jun 2012
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Frediani M, Blanchini G, Capanna M, Casini L, Costa M, Uggeri S, Meini M, Pacini P. [The laryngeal mask in pediatric anesthesia]. Minerva Anestesiol. 1996 Mar;62(3):65-71. Italian.
PubMed 8767151Brain AI. The laryngeal mask--a new concept in airway management. Br J Anaesth. 1983 Aug;55(8):801-5. doi: 10.1093/bja/55.8.801.
PubMed 6349667Samarkandi AH. Awake removal of the laryngeal mask airway is safe in paediatric patients. Can J Anaesth. 1998 Feb;45(2):150-2. doi: 10.1007/BF03013254.
PubMed 9512850Splinter WM, Reid CW. Removal of the laryngeal mask airway in children: deep anesthesia versus awake. J Clin Anesth. 1997 Feb;9(1):4-7. doi: 10.1016/S0952-8180(96)00217-6.
PubMed 9051538Nunez J, Hughes J, Wareham K, Asai T. Timing of removal of the laryngeal mask airway. Anaesthesia. 1998 Feb;53(2):126-30. doi: 10.1046/j.1365-2044.1998.00298.x.
PubMed 9534633Pappas AL, Sukhani R, Lurie J, Pawlowski J, Sawicki K, Corsino A. Severity of airway hyperreactivity associated with laryngeal mask airway removal: correlation with volatile anesthetic choice and depth of anesthesia. J Clin Anesth. 2001 Nov;13(7):498-503. doi: 10.1016/s0952-8180(01)00318-x.
PubMed 11704447Baird MB, Mayor AH, Goodwin AP. Removal of the laryngeal mask airway: factors affecting the incidence of post-operative adverse respiratory events in 300 patients. Eur J Anaesthesiol. 1999 Apr;16(4):251-6. doi: 10.1046/j.1365-2346.1999.00476.x.
PubMed 10234495Kitching AJ, Walpole AR, Blogg CE. Removal of the laryngeal mask airway in children: anaesthetized compared with awake. Br J Anaesth. 1996 Jun;76(6):874-6. doi: 10.1093/bja/76.6.874.
PubMed 8679367Afshan G, Chohan U, Qamar-Ul-Hoda M, Kamal RS. Is there a role of a small dose of propofol in the treatment of laryngeal spasm? Paediatr Anaesth. 2002 Sep;12(7):625-8. doi: 10.1046/j.1460-9592.2002.00937.x.
PubMed 12358660
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isoflurane Versus Combination Of Propofol With Isoflurane For Removal Of Laryngeal Mask Airway In Children
- ClinicalTrials.gov ID
- NCT01958138
- Acronym / sponsor ID
- 1995-Ane-ERC-11
- Conditions
- Complication of Anesthesia
- Keywords
- Laryngeal Mask Airway, Propofol, Isoflurane, Pediatric patients, Emergence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Oct 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.
The study will be done in paediatric patients by comparing two different techniques of Laryngeal Mask Airway (LMA) removal under deep anesthetic plane.
The both study techniques will be compared for safe LMA removal on the basis of adverse airway events and emergence time duration and recovery room stay timing.
Detailed description
- Study will be start after confirming the approval of institutional ethical review committee and after fulfilling the study inclusion criteria. The detailed study protocol will be explain to the parent/guardian and written \& informed consent will be taking on his/her will.
- Inclusion Criteria
- Age between 2 to 10 years,
- American Society of Anaesthesiologists (ASA) physical status I \& II,
- Patient is not contraindicated to Laryngeal Mask Airway insertion,
- Elective below umbilical general surgical procedures
- patient is planned for general anesthesia with spontaneous breathing.
- Fifty patients will participate in both study groups.
- All patients will be premedicated with oral midazolam 0.3mg/kg, 45 to 60 minutes prior to induction.
- After arrival of patients in operating room, routine anesthesia monitoring will be applied and baseline blood pressure, heart rate, respiratory rate and oxygen saturation will be recorded.
- Patient will be induced with anesthetic induction inhalational agent (sleeping drug) sevoflurane 8% with oxygen by pediatric anesthesia circle system. The sevoflurane concentration will be adjusted to 3% to 4% once the adequate depth of anesthesia achieved, as evident by jaw relaxation and tolerance of an oral airway.
- The LMA will be placed after the insertion of intravenous line.
- The LMA size will be determined as per manufacturer's recommendation; which suggest 1.5 LMA size for 5-10 kg, size 2 for 10-20 kg and size 2.5 for 20-30 kg.
- The anesthesia will be maintained with isoflurane in 60% nitrous oxide and 40% oxygen. Patients will be ventilated by spontaneous mode by 'Mapleson F anesthesia circuit' and for above 25 Kg patient, the circle system will be used.
- Caudal analgesia was standardised in both study groups.
- Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I.
The group-II LMA will removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen. In both groups; LMA will be removed with inflated cuff, throat was suctioned and patients were turned into lateral recovery position.
Isoflurane and nitrous oxide were turned off and 100% oxygen supplemented till the patient had regained consciousness. All participants were transported to Post Anesthesia Care Unit (PACU) once ensured airway patency and peripheral oxygen saturation (Sp02) greater than 93% on room air. Children were allowed to wake up effortlessly in PACU at oxygen 5 litters/minutes via Hudson mask.
- The following study variables will be recorded;
- Emergence time ( patient awakening time),
- Duration of recovery room stay (Post anesthesia care unit),
- Smooth Laryngeal Mask Airway removal will be assessed by
- Cough,
- Hypersalivation,
- 02 desaturation < 90%,
- Teeth clenching,
- Airway obstruction requiring jaw support,
- Laryngospasm,
- Bronchospasm,
- Retching,
- Vomiting,
- Confounding variables will be assessed like;
- Patients demographics,
- Duration of surgery,
- Duration of anesthesia,
- Type of surgery,
- Mode of analgesia
- Number of Laryngeal Mask Airway insertion attempts:
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol with Isoflurane | Experimental | Drug: comparison of group-I (low dose propofol with isoflurane)Propofol with Isoflurane, Group-I is the intervention arm with combination of two drugs such as low dose propofol and Isoflurane MAC awake. |
| alone isoflurane | Active comparator | Drug: comparison of group-I (low dose propofol with isoflurane)The group-II is the control arm of study by using the only Isoflurane 1.2 MAC |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- American Society of Anesthesiologist class-I \& II patients.
- mallampatis class I \& II.
- Age from 2 years to 10 years.
- Elective surgical patients for below umbilical general surgical procedures.
Key exclusion criteria (7 listed)
- Congenital disorders
- Airway or facial abnormalities
- Reactive airway disease/asthma
- Anticipated difficult airway
- History of Upper respiratory tract infection in last 3 weeks
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 |
|---|---|---|
| comparison of group-I (low dose propofol with isoflurane)Also: group-II (alone isoflurane MAC 1.2%)Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I. The group-II LMA will be removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen | Drug | alone isoflurane, propofol with Isoflurane |
Primary outcome
Emergence airway complications
Time frame: 15 minutes of continuous monitoring and time frame was started from the LMA removal
Smooth LMA removal will be assessed by adverse airway events like; coughing, bucking, hypersalivation, O2 desaturation (Sp02<90%), airway obstruction (noisy or stridor breathing) requiring jaw support, laryngospasm, bronchospasm, retching and vomiting, time duration from LMA removal up to 15 minutes.
Emergence time duration
Time frame: 15 minutes of continuous monitoring and time frame was started from the LMA removal
Impact on emergence time duration because of intervention such as delayed awakening or responding
Post anaesthesia care unit stay time duration
Time frame: 0-45 minutes of continuous monitoring and time frame was started from the PACU admission to discharge
Impact of intervention on post anaesthesia care unit admission to discharge time duration
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 15 Feb 2021.
- Background: PubMed 8767151Frediani M, Blanchini G, Capanna M, Casini L, Costa M, Uggeri S, Meini M, Pacini P. [The laryngeal mask in pediatric anesthesia]. Minerva Anestesiol. 1996 Mar;62(3):65-71. Italian.
- Background: PubMed 6349667Brain AI. The laryngeal mask--a new concept in airway management. Br J Anaesth. 1983 Aug;55(8):801-5. doi: 10.1093/bja/55.8.801.
- Background: PubMed 9512850Samarkandi AH. Awake removal of the laryngeal mask airway is safe in paediatric patients. Can J Anaesth. 1998 Feb;45(2):150-2. doi: 10.1007/BF03013254.
- Background: PubMed 9051538Splinter WM, Reid CW. Removal of the laryngeal mask airway in children: deep anesthesia versus awake. J Clin Anesth. 1997 Feb;9(1):4-7. doi: 10.1016/S0952-8180(96)00217-6.
- Background: PubMed 9534633Nunez J, Hughes J, Wareham K, Asai T. Timing of removal of the laryngeal mask airway. Anaesthesia. 1998 Feb;53(2):126-30. doi: 10.1046/j.1365-2044.1998.00298.x.
- Background: PubMed 11704447Pappas AL, Sukhani R, Lurie J, Pawlowski J, Sawicki K, Corsino A. Severity of airway hyperreactivity associated with laryngeal mask airway removal: correlation with volatile anesthetic choice and depth of anesthesia. J Clin Anesth. 2001 Nov;13(7):498-503. doi: 10.1016/s0952-8180(01)00318-x.
- Background: PubMed 10234495Baird MB, Mayor AH, Goodwin AP. Removal of the laryngeal mask airway: factors affecting the incidence of post-operative adverse respiratory events in 300 patients. Eur J Anaesthesiol. 1999 Apr;16(4):251-6. doi: 10.1046/j.1365-2346.1999.00476.x.
- Background: PubMed 8679367Kitching AJ, Walpole AR, Blogg CE. Removal of the laryngeal mask airway in children: anaesthetized compared with awake. Br J Anaesth. 1996 Jun;76(6):874-6. doi: 10.1093/bja/76.6.874.
- Background: PubMed 12358660Afshan G, Chohan U, Qamar-Ul-Hoda M, Kamal RS. Is there a role of a small dose of propofol in the treatment of laryngeal spasm? Paediatr Anaesth. 2002 Sep;12(7):625-8. doi: 10.1046/j.1460-9592.2002.00937.x.
- Individual participant dataSharing planned: No
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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.
dileep kumar, FCPS principal investigator
Aga Khan University Hospital Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing comparison of group-I (low dose propofol with isoflurane) in people with Complication of Anesthesia, run by Aga Khan University at 1 site in Pakistan.
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 4 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 15 Feb 2021. 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 Pakistan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Emergence airway complications (time frame: 15 minutes of continuous monitoring and time frame was started from the LMA removal). The study lists 3 primary outcomes in all. 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 NCT01958138, which also lists 9 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 15 Feb 2021.