Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Recovery After Laparoscopic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992640
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):
Anne Kathrine Staehr-Rye, Herlev Hospital

Brief Summary:

During laparoscopic surgery, muscle relaxants are often administrated in order to ensure acceptable surgical conditions. These drugs bind to receptors in the neuromuscular junction.

The degree of muscle relaxation is monitored by use of an acceleromyography and at the end of surgery another drug - Neostigmine- is given to reverse the muscle relaxation. However,there may still be a blockade of up to 70% of the receptors.

This partial muscle relaxation may result in muscle weakness, reduced balance and prolonged hospitalization.

This study will describe changes in balance and subjective muscle weakness after laparoscopic surgery.

The primary hypothesis is that sway area is increased 30 min after extubation compared to the preoperative value.


Condition or disease
Laparoscopy

Layout table for study information
Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Recovery After Laparoscopic Surgery
Study Start Date : December 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014



Primary Outcome Measures :
  1. Change in postural sway area 30 min after extubation (closed eyes) [ Time Frame: Preoperatively and 30 min after extubation ]

Secondary Outcome Measures :
  1. Change in sway area when ready to be discharge form the postoperative care unit (PACU)(closed eyes) [ Time Frame: Preoperatively and at discharge from the PACU. An expected duration of 2 hours after surgery ]
  2. change in sway area 30 min after extubation (open eyes) [ Time Frame: Preoperatively and 30 min after extubation ]
  3. Change in sway area when ready to be discharged from the PACU (open eyes) [ Time Frame: Preoperatively and when ready to be discharged from the PACU. An expected average of 2 hours after surgery ]
  4. Change in sway velocity 30 min after extubation (closed eyes) [ Time Frame: Preoperatively and 30 min after extubation ]
  5. Change in sway velocity 30 min after extubation (open eyes) [ Time Frame: Preoperatively and 30 min after extubation ]
  6. Change in sway velocity when ready to be discharged from the PACU (closed eyes) [ Time Frame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery ]
  7. Change in sway velocity when ready to be discharged from the PACU (open eyes) [ Time Frame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery ]
  8. Change in mean sway 30 min after extubation (closed eyes) [ Time Frame: Preoperatively and 30 min after extubation ]
  9. Change in mean sway 30 min after extubation (open eyes) [ Time Frame: Preoperatively and 30 min after extubation ]
  10. Change in mean sway when ready to discharge from the PACU (closed eyes) [ Time Frame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery. ]
  11. Change in mean sway when ready to be discharged from the PACU (open eyes) [ Time Frame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery ]
  12. Change in subjective balance 30 min after extubation [ Time Frame: Preoperatively and 30 min after extubation ]
  13. Change in subjective balance when ready to be discharged from the PACU [ Time Frame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery ]
  14. Change in muscle weakness 30 min after extubation [ Time Frame: Preoperatively and 30 min after extubation ]
  15. Change in muscle weakness when ready to be discharged from the PACU [ Time Frame: preoperatively and when ready to be discharge from the PACU. An expected duration of 2 hours ]
  16. Incidence of critical respiratory events from extubation until discharge from the PACU [ Time Frame: From extubation until discharge from the PACU (approximately 2 hours) ]
  17. Duration of stay at the PACU [ Time Frame: The patients will be followed from extubation until leaving the PACU. An expected average duration of 2 hours ]
  18. Duration of postoperative hospitalization [ Time Frame: The patient will be followed from extubation until discharge from hospital. An expected average duration of 12 hours ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients scheduled for laparoscopic surgery at Herlev Hospital and expected discharge on the same day as surgery.
Criteria

Inclusion Criteria:

  • Age above 18 years
  • Same-day gynaecological laparoscopic surgery
  • Informed consent

Exclusion Criteria:

  • Body mass index above 30 kg/m2
  • Insufficient renal function
  • Liver insufficience
  • Neuromuscular monitoring not possible
  • Known allergy towards medicine used in the protocol
  • Daily use of opioids
  • Known disease which can interfere with the balance
  • Pregnant/lactating
  • Cannot read or understand danish
  • Fast-track intubation with use of succinylcholine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992640


Locations
Layout table for location information
Denmark
Dept. of Anesthesiology, University of Copenhagen, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Layout table for investigator information
Principal Investigator: Anne K Staehr-Rye, M.D. Dept. of Anesthesiology, Herlev Hospital
Study Chair: Mona R Gätke, M.D.; Ph.D. Dept. of Anesthesiology, Herlev Hospital
Layout table for additonal information
Responsible Party: Anne Kathrine Staehr-Rye, M.D., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01992640    
Other Study ID Numbers: 11-2013
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014