Prone Position Emergence From Anaesthesia in Lumbar Disc Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
shivakumar m c, KVG Medical College and Hospital
ClinicalTrials.gov Identifier:
NCT01441700
First received: September 24, 2011
Last updated: September 27, 2011
Last verified: September 2011

September 24, 2011
September 27, 2011
August 2010
August 2011   (final data collection date for primary outcome measure)
  • Heart rate changes from conclusion of surgery to extubation [ Time Frame: From conlusion surgery to extubation of patient ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
Same as current
Complete list of historical versions of study NCT01441700 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Haemodynamic Changes During During Emergence
  • Airway Response During Emergence
  • Monitor Disconnection During Emergence
Procedure: Prone and Supine emergence from anaesthesia
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: Prone position
    Intervention: Procedure: Prone and Supine emergence from anaesthesia
  • Active Comparator: Supine position
    Intervention: Procedure: Prone and Supine emergence from anaesthesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01441700
SMC/CT/1/2010, KVGMCH/CT/1/2010
No
shivakumar m c, KVG Medical College and Hospital
KVG Medical College and Hospital
Not Provided
Principal Investigator: SHIVAKUMAR MC, MD KVG Medical College and Hospital
KVG Medical College and Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP