- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01441700
Prone Position Emergence From Anaesthesia in Lumbar Disc Surgery
A Comparative Study of Haemodynamic Changes Between Prone and Supine Emergence From Anaesthesia in Lumbar Disc Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18-60 years
- prone surgery
- lumbar disc surgery
Exclusion Criteria:
- suspected difficult airway,
- risk factors for perioperative aspiration,
- chronic coughing,
- recent history of respiratory tract infection,
- chronic obstructive lung disease and
- obesity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Prone position
|
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
|
ACTIVE_COMPARATOR: Supine position
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From conlusion surgery to extubation of patient
|
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.
|
From conclusion of surgery to extubation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: SHIVAKUMAR MC, MD, KVG Medical College and Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC/CT/1/2010
- KVGMCH/CT/1/2010 (OTHER: KVGMCH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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