NCT01441700

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
Last Updated

September 28, 2011

Status Verified

September 1, 2011

Enrollment Period

1 year

First QC Date

September 24, 2011

Last Update Submit

September 27, 2011

Conditions

Keywords

Prone emergencesupine emergencecoughinghaemodynamic stimulationlumbar surgery

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From conclusion of surgery to extubation

Study Arms (2)

Prone position

ACTIVE COMPARATOR
Procedure: Prone and Supine emergence from anaesthesia

Supine position

ACTIVE COMPARATOR
Procedure: Prone and Supine emergence from anaesthesia

Interventions

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

Prone positionSupine position

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18-60 years
  • prone surgery
  • lumbar disc surgery

You may not qualify if:

  • suspected difficult airway,
  • risk factors for perioperative aspiration,
  • chronic coughing,
  • recent history of respiratory tract infection,
  • chronic obstructive lung disease and
  • obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cough

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • SHIVAKUMAR MC, MD

    KVG Medical College and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 24, 2011

First Posted

September 28, 2011

Study Start

August 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

September 28, 2011

Record last verified: 2011-09