Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anesthesia
  • Pain Acute
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: RCTMasking: Single (Investigator)Masking Description: control group will be masked so that the monitor index will not be seen by the caregiver/investigator.Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Investigators study patients undergoing functional endoscopic sinus surgery (FESS), concaplasty or lateral rhinotomy and who receive routine general anesthesia (anesthesia). These patients often have an age between 30-60 years and not infrequently assessed with regard to intraoperative and postopera...

Investigators study patients undergoing functional endoscopic sinus surgery (FESS), concaplasty or lateral rhinotomy and who receive routine general anesthesia (anesthesia). These patients often have an age between 30-60 years and not infrequently assessed with regard to intraoperative and postoperative pain response. During the anesthesia study and after anesthesia, an equipment that monitors the pain response NoL (pain monitor) is used. This kind of pain monitor has been around for about 10 years. Over the past 5 years, its technology has evolved so much that in various countries it has become a monitoring system that is used as a complement to anesthesia. The study will be a randomized intervention study in which the random determines whether the patient's pain level is monitored using NoL or only according to traditional clinical assessment intra- and post-operatively. The patient will be assessed with the post-Qrs test, partly preoperatively (baseline) and partly post-operatively to assess the rate of recovery compared to baseline. The collected data is analyzed afterwards to possibly determine whether it is possible to determine differences in recovery, based on choice of pain monitoring method (Pain NoL or clinical assessment, pulse, blood pressure, BIS index, NoL index, amount of opioid intraoperatively and opioid amount postoperatively, VAS / NRS). Patients included in the study will be persons over the age of 18 and who agree to participate. Both women and men are included. Exclusion criteria include problems with the Swedish language or other communicative difficulties that make the assessment more difficult and patients with pacemakers. Both groups are anesthetized with propofol infusion and oxygen in the air, which is given analgesic remifentanil during surgery. Randomization is done through mixed, closed envelopes. Prior to the anesthesia, extra oxygen will be added and standard monitoring will be connected to the patient (ECG, noninvasive blood pressure measurement, saturation, NMT, NoL). Form, Postop-QRS test, with questions will be reviewed with the patient the day before or the same day as the surgery and postoperatively. The tests are intended to measure alertness, pain, nausea, vomiting and cognitive function and general recovery. The BIS index, NoL index, heart rate, blood pressure and saturation are regularly measured and recorded in special protocol. (NoL blinded, these index values are stored directly from the monitor on a so-called USB memory stick)

Tracking Information

NCT #
NCT04114851
Collaborators
Not Provided
Investigators
Not Provided