Haemodynamic Changes During During EmergenceNCT01441700
Prone Position Emergence From Anaesthesia in Lumbar Disc Surgery
A study testing Prone and Supine emergence from anaesthesia in people with Haemodynamic Changes During During Emergence and Airway Response During Emergence, run by KVG Medical College and Hospital.
Trial summary
Compare haemodynamic changes and to evaluate the incidence of coughing, laryngospasm, loss of monitoring in patients undergoing lumbar disc surgery extubated in prone position and supine position. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Haemodynamic Changes During During Emergence, Airway Response During Emergence, Monitor Disconnection During Emergence
- What is being tested?
- Prone and Supine emergence from anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Sep 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18-60 years
- prone surgery
- lumbar disc surgery
Who cannot join
- suspected difficult airway,
- risk factors for perioperative aspiration,
- chronic coughing,
- recent history of respiratory tract infection,
- chronic obstructive lung disease and
- obesity
About this study
Official title: A Comparative Study of Haemodynamic Changes Between Prone and Supine Emergence From Anaesthesia in Lumbar Disc Surgery
Compare haemodynamic changes and to evaluate the incidence of coughing, laryngospasm, loss of monitoring in patients undergoing lumbar disc surgery extubated in prone position and supine position.
Read the detailed description
Tracheal irritation from the endotracheal tube, with subsequent coughing is common during emergence from general anaesthesia supine position and is often thought not to be a complication, but a physiological response to protect the airway from aspiration, although the side-effects of this vital reflex may be highly undesirable in clinical practice.
Coughing not only causes significant patient discomfort, but it may also cause hypertension, tachycardia, and increased intracranial, intraocular, and intra-abdominal pressure, which may lead to myocardial ischemia, arrhythmias, or surgical complications. Supine extubation also leads increased incidences of breath holding, laryngospasm, coughing, and monitor disconnection. These haemodynamic and airway responses are largely related movement of endotracheal tube during rolling of patients back to supine position during lighter depth of anaesthesia at conclusion of surgery. Coughing, breath holding, and laryngospasm also related to pooling of secretions to dependent patients airway in supine position.
Various techniques and drugs for the prevention of cardiovascular response and coughing during emergence have been studied, including extubation in a deep plane of anaesthesia, administration of intravenous drugs such as esmolol, lidocaine, short-acting opioids, or dexmedetomidine, and intracuff lidocaine. A reliable means of preventing undesired coughing has not been demonstrated to date.
Emergence in prone position has been found to be associated with less hemodynamic alterations, less coughing, laryngospasm, vomiting and monitor disconnections in patients undergoing lumbar surgery. There is a paucity of data regarding safety and efficacy of emergence from anaesthesia in prone position. The investigators present our initial experience of emergence from anaesthesia in prone position as compared to supine position in normotensive patients undergoing lumbar surgery in prone position.
- Conditions
- Haemodynamic Changes During During Emergence, Airway Response During Emergence, Monitor Disconnection During Emergence
- Being tested
- Prone and Supine emergence from anaesthesia
- Keywords
- Prone emergence, supine emergence, coughing, haemodynamic stimulation, lumbar surgery
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone and Supine emergence from anaesthesiaProcedure or surgery
Aims: The aim of this study was to compare haemodynamic changes and to evaluate the incidence of coughing, laryngospasm, loss of monitoring in patients undergoing lumbar disc surgery extubated in prone position and supine position. Settings and design: This open-level prospective randomized study was carried out in 50 patients who were admitted for elective lumbar surgery. Methods: The patients were randomly allocated to one of the two groups of 25 each at conclusion of surgery. First group was extubated in prone position and second in supine position at conclusion of surgery. Supine group patients were rolled back and prone group patients were left undisturbed. Extubation was done after complete reversal of neuromuscular block. Heart rates, Mean Arterial Pressure were noted at various points of time. Coughing, laryngospasm, vomiting, monitor disconnection if any were also noted. Statistical methods: Data was analyzed using
| Study group | Role | What they receive |
|---|---|---|
| Prone position | Active comparator | Not described Receives: Procedure: Prone and Supine emergence from anaesthesia |
| Supine position | Active comparator | Not described Receives: Procedure: Prone and Supine emergence from anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate changes from conclusion of surgery to extubation
Heart rate and mean arterial pressure were recorded each minute till extubation Coughs, vomiting, laryngospasm and monitor disconnections were also recorded from conclusion of surgery (T0) till extubation.
Measured: From conlusion surgery to extubation of patient
Mean arterial pressure changes during emergence from anaesthesia
Heart rate and mean arterial pressure were recorded each minute till extubation Coughs, vomiting, laryngospasm and monitor disconnections were also recorded from conclusion of surgery (T0) till extubation.
Measured: From conclusion of surgery to extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodynamic Changes During During EmergenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KVG Medical College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shivakumar m c, KVG Medical College and Hospital
- Investigators
- SHIVAKUMAR MC, MD, Principal investigator, KVG Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441700
- Sponsor's protocol ID
- SMC/CT/1/2010
- Other IDs
- KVGMCH/CT/1/2010
- Status last verified
- Sep 2011
- First submitted
- 24 Sep 2011
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Haemodynamic Changes Between Prone and Supine Emergence From Anaesthesia in Lumbar Disc Surgery
- ClinicalTrials.gov ID
- NCT01441700
- Acronym / sponsor ID
- SMC/CT/1/2010
- Conditions
- Haemodynamic Changes During During Emergence, Airway Response During Emergence, Monitor Disconnection During Emergence
- Keywords
- Prone emergence, supine emergence, coughing, haemodynamic stimulation, lumbar surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KVG Medical College and HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Sep 2011 (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.
Compare haemodynamic changes and to evaluate the incidence of coughing, laryngospasm, loss of monitoring in patients undergoing lumbar disc surgery extubated in prone position and supine position.
Detailed description
Tracheal irritation from the endotracheal tube, with subsequent coughing is common during emergence from general anaesthesia supine position and is often thought not to be a complication, but a physiological response to protect the airway from aspiration, although the side-effects of this vital reflex may be highly undesirable in clinical practice.
Coughing not only causes significant patient discomfort, but it may also cause hypertension, tachycardia, and increased intracranial, intraocular, and intra-abdominal pressure, which may lead to myocardial ischemia, arrhythmias, or surgical complications. Supine extubation also leads increased incidences of breath holding, laryngospasm, coughing, and monitor disconnection. These haemodynamic and airway responses are largely related movement of endotracheal tube during rolling of patients back to supine position during lighter depth of anaesthesia at conclusion of surgery. Coughing, breath holding, and laryngospasm also related to pooling of secretions to dependent patients airway in supine position.
Various techniques and drugs for the prevention of cardiovascular response and coughing during emergence have been studied, including extubation in a deep plane of anaesthesia, administration of intravenous drugs such as esmolol, lidocaine, short-acting opioids, or dexmedetomidine, and intracuff lidocaine. A reliable means of preventing undesired coughing has not been demonstrated to date.
Emergence in prone position has been found to be associated with less hemodynamic alterations, less coughing, laryngospasm, vomiting and monitor disconnections in patients undergoing lumbar surgery. There is a paucity of data regarding safety and efficacy of emergence from anaesthesia in prone position. The investigators present our initial experience of emergence from anaesthesia in prone position as compared to supine position in normotensive patients undergoing lumbar surgery in prone position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone position | Active comparator | Procedure: Prone and Supine emergence from anaesthesia |
| Supine position | Active comparator | Procedure: Prone and Supine emergence from anaesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18-60 years
- prone surgery
- lumbar disc surgery
Key exclusion criteria (6 listed)
- suspected difficult airway,
- risk factors for perioperative aspiration,
- chronic coughing,
- recent history of respiratory tract infection,
- chronic obstructive lung disease and
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 |
|---|---|---|
| Prone and Supine emergence from anaesthesiaAims: The aim of this study was to compare haemodynamic changes and to evaluate the incidence of coughing, laryngospasm, loss of monitoring in patients undergoing lumbar disc surgery extubated in prone position and supine position. Settings and design: This open-level prospective randomized study was carried out in 50 patients who were admitted for elective lumbar surgery. Methods: The patients were randomly allocated to one of the two groups of 25 each at conclusion of surgery. First group was extubated in prone position and second in supine position at conclusion of surgery. Supine group patients were rolled back and prone group patients were left undisturbed. Extubation was done after complete reversal of neuromuscular block. Heart rates, Mean Arterial Pressure were noted at various points of time. Coughing, laryngospasm, vomiting, monitor disconnection if any were also noted. Statistical methods: Data was analyzed using | Procedure or surgery | Prone position, Supine position |
Primary outcome
Heart rate changes from conclusion of surgery to extubation
Time frame: From conlusion surgery to extubation of patient
Heart rate and mean arterial pressure were recorded each minute till extubation Coughs, vomiting, laryngospasm and monitor disconnections were also recorded from conclusion of surgery (T0) till extubation.
Mean arterial pressure changes during emergence from anaesthesia
Time frame: From conclusion of surgery to extubation
Heart rate and mean arterial pressure were recorded each minute till extubation Coughs, vomiting, laryngospasm and monitor disconnections were also recorded from conclusion of surgery (T0) till extubation.
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 28 Sep 2011.
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.
SHIVAKUMAR MC, MD principal investigator
KVG Medical College and Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Prone and Supine emergence from anaesthesia in people with Haemodynamic Changes During During Emergence and Airway Response During Emergence, run by KVG Medical College and Hospital.
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 3 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 28 Sep 2011. 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?
Heart rate changes from conclusion of surgery to extubation (time frame: From conlusion surgery to extubation of patient). The study lists 2 primary outcomes in all. 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 28 Sep 2011.