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Completed

NCT Number: NCT01992640

Recovery After Laparoscopic Surgery

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.

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Key information

Conditions

Laparoscopy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Dept. of Anesthesiology, University of Copenhagen, Herlev Hospital

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in postural sway area 30 min after extubation (closed eyes)

    Time frame: Preoperatively and 30 min after extubation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2013
Registry last updated
Jun 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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