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.

Study Overview

• Status: Completed
• Conditions: Laparoscopy

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Dept. of Anesthesiology, University of Copenhagen, Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in postural sway area 30 min after extubation (closed eyes)	Preoperatively and 30 min after extubation

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 sway velocity 30 min after extubation (closed 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 (closed eyes)	Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
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 30 min after extubation (closed eyes)	Preoperatively and 30 min after extubation
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 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 30 min after extubation	Preoperatively and 30 min after extubation
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
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
Duration of postoperative hospitalization	The patient will be followed from extubation until discharge from hospital. An expected average duration of 12 hours

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): June 20, 2014
• Last Update Submitted That Met QC Criteria: June 18, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 11-2013