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Clinical Trials/NCT01992640
NCT01992640CompletedNot Applicable

Recovery After Laparoscopic Surgery

Herlev Hospital1 site in 1 country25 target enrollmentStarted: December 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
Change in postural sway area 30 min after extubation (closed eyes)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: Preoperatively and 30 min after extubation

Secondary Outcomes

  • Change in sway velocity when ready to be discharged from the PACU (closed eyes)(Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery)
  • Change in sway velocity 30 min after extubation (closed eyes)(Preoperatively and 30 min after extubation)
  • Change in sway area when ready to be discharged from the PACU (open eyes)(Preoperatively and when ready to be discharged from the PACU. An expected average of 2 hours after surgery)
  • Change in mean sway 30 min after extubation (closed eyes)(Preoperatively and 30 min after extubation)
  • Change in subjective balance 30 min after extubation(Preoperatively and 30 min after extubation)
  • Change in sway area when ready to be discharge form the postoperative care unit (PACU)(closed eyes)(Preoperatively and at discharge from the PACU. An expected duration of 2 hours after surgery)
  • change in sway area 30 min after extubation (open eyes)(Preoperatively and 30 min after extubation)
  • Change in sway velocity 30 min after extubation (open eyes)(Preoperatively and 30 min after extubation)
  • Change in sway velocity when ready to be discharged from the PACU (open eyes)(Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery)
  • Change in mean sway when ready to be discharged from the PACU (open eyes)(Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery)
  • Change in subjective balance when ready to be discharged from the PACU(Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery)
  • Duration of postoperative hospitalization(The patient will be followed from extubation until discharge from hospital. An expected average duration of 12 hours)
  • Change in mean sway 30 min after extubation (open eyes)(Preoperatively and 30 min after extubation)
  • Change in mean sway when ready to discharge from the PACU (closed eyes)(Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery.)
  • Change in muscle weakness 30 min after extubation(Preoperatively and 30 min after extubation)
  • Change in muscle weakness when ready to be discharged from the PACU(preoperatively and when ready to be discharge from the PACU. An expected duration of 2 hours)
  • Incidence of critical respiratory events from extubation until discharge from the PACU(From extubation until discharge from the PACU (approximately 2 hours))
  • Duration of stay at the PACU(The patients will be followed from extubation until leaving the PACU. An expected average duration of 2 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anne Kathrine Staehr-Rye

M.D.

Herlev Hospital

Study Sites (1)

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