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
  Purpose

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.


Condition Intervention
Haemodynamic Changes During During Emergence
Airway Response During Emergence
Monitor Disconnection During Emergence
Procedure: Prone and Supine emergence from anaesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study of Haemodynamic Changes Between Prone and Supine Emergence From Anaesthesia in Lumbar Disc Surgery

Resource links provided by NLM:


Further study details as provided by KVG Medical College and Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prone position 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: Supine position 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441700

Sponsors and Collaborators
KVG Medical College and Hospital
Investigators
Principal Investigator: SHIVAKUMAR MC, MD KVG Medical College and Hospital
  More Information

No publications provided

Responsible Party: shivakumar m c, Assistant professor, KVG Medical College and Hospital
ClinicalTrials.gov Identifier: NCT01441700     History of Changes
Other Study ID Numbers: SMC/CT/1/2010, KVGMCH/CT/1/2010
Study First Received: September 24, 2011
Last Updated: September 27, 2011
Health Authority: India: Ministry of Health

Keywords provided by KVG Medical College and Hospital:
Prone emergence
supine emergence
coughing
haemodynamic stimulation
lumbar surgery

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014