Clinical trial NCT01992640: Recovery After Laparoscopic Surgery
Official title: Recovery After Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Change in postural sway area 30 min after extubation (closed eyes)
timeFrame: Preoperatively and 30 min after extubation
Secondary outcomes:
measure: Change in sway area when ready to be discharge form the postoperative care unit (PACU)(closed eyes)
timeFrame: Preoperatively and at discharge from the PACU. An expected duration of 2 hours after surgery
measure: change in sway area 30 min after extubation (open eyes)
timeFrame: Preoperatively and 30 min after extubation
measure: Change in sway area when ready to be discharged from the PACU (open eyes)
timeFrame: Preoperatively and when ready to be discharged from the PACU. An expected average of 2 hours after surgery
measure: Change in sway velocity 30 min after extubation (closed eyes)
timeFrame: Preoperatively and 30 min after extubation
measure: Change in sway velocity 30 min after extubation (open eyes)
timeFrame: Preoperatively and 30 min after extubation
measure: Change in sway velocity when ready to be discharged from the PACU (closed eyes)
timeFrame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
measure: Change in sway velocity when ready to be discharged from the PACU (open eyes)
timeFrame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
measure: Change in mean sway 30 min after extubation (closed eyes)
timeFrame: Preoperatively and 30 min after extubation
measure: Change in mean sway 30 min after extubation (open eyes)
timeFrame: Preoperatively and 30 min after extubation
measure: Change in mean sway when ready to discharge from the PACU (closed eyes)
timeFrame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery.
measure: Change in mean sway when ready to be discharged from the PACU (open eyes)
timeFrame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
measure: Change in subjective balance 30 min after extubation
timeFrame: Preoperatively and 30 min after extubation
measure: Change in subjective balance when ready to be discharged from the PACU
timeFrame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
measure: Change in muscle weakness 30 min after extubation
timeFrame: Preoperatively and 30 min after extubation
measure: Change in muscle weakness when ready to be discharged from the PACU
timeFrame: preoperatively and when ready to be discharge from the PACU. An expected duration of 2 hours
measure: Incidence of critical respiratory events from extubation until discharge from the PACU
timeFrame: From extubation until discharge from the PACU (approximately 2 hours)
measure: Duration of stay at the PACU
timeFrame: The patients will be followed from extubation until leaving the PACU. An expected average duration of 2 hours
measure: Duration of postoperative hospitalization
timeFrame: The patient will be followed from extubation until discharge from hospital. An expected average duration of 12 hours
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Dept. of Anesthesiology, University of Copenhagen, Herlev Hospital
Study officials:
affiliation: Dept. of Anesthesiology, Herlev Hospital
name: Anne K Staehr-Rye, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Anesthesiology, Herlev Hospital
name: Mona R Gätke, M.D.; Ph.D.
role: STUDY_CHAIR
References: