Prone Position Emergence From Anaesthesia in Lumbar Disc Surgery

September 27, 2011 updated by: shivakumar m c, KVG Medical College and Hospital

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.

Study Overview

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: SHIVAKUMAR MC, MD, KVG Medical College and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

September 24, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (ESTIMATE)

September 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2011

Last Update Submitted That Met QC Criteria

September 27, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

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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