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Use of Dexmedetomidine for Deep Sedation in Patients Undergoing Outpatient Hysteroscopic Surgery

Use of Dexmedetomidine for Deep Sedation in Patients Undergoing Outpatient Hysteroscopic Surgery

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01337739
Enrollment
8
Registered
2011-04-19
Start date
2010-10-31
Completion date
2012-04-30
Last updated
2013-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Hysteroscopic Surgery, Dexmedetomidine, Sedation, Opioids

Brief summary

Patients undergoing deep sedation for outpatient procedures typically receive a combination of benzodiazepines, propofol, and opioids. Side effects of such anesthetics include respiratory depression, nausea and vomiting, and urinary retention, with resultant extended hospital stays and unanticipated admission. The use of dexmedetomidine for deep sedation may increase patient safety by maintaining respiratory drive, while providing sedation, hypnosis, and analgesia. Furthermore, patients may experience decreased pain, nausea, and time to discharge in the PACU, especially if dexmedetomidine decreases the requirement of other drugs such as opioids. The hypothesis of this study is administration of dexmedetomidine during deep sedation for ambulatory hysteroscopic surgery will result in a 50% reduction of intraoperative opioid compared to sedation with propofol.

Detailed description

Patients will be recruited up to 21 days prior to the day of surgery. Preoperatively: A full preoperative assessment will be completed. Preoperatively, patients will be instructed on the proper use of the verbal rating scale (VRS) for pain and nausea scores. Patients will be randomized by a computer-generated scheme to receive prepared infusions containing either dexmedetomidine (4grams per milliliter or propofol (10 milligrams per milliliter) intraoperatively. The study drug infusions will be prepared by study personnel who are not involved in the assessments. Patients, medical personnel other than the anesthesiologist, and outcome assessors will be blinded to treatment allocation. Only the anesthesiologist administering the treatment infusion and medications intraoperatively will be aware of group allocation. Intraoperatively: A standardized intraoperative anesthetic plan will be utilized by the anesthesia personnel.All patients will receive premedication with midazolam 2 milligrams intravenous bolus and ketorolac 30 milligrams via the intravenous catheter. Intraoperative monitoring will include standard monitoring which includes noninvasive blood pressure, electrocardiography, pulse oximetry, and capnography. In addition transcutaneous CO2 will be monitored using the Tosca monitor.(Radiometer, Basel, Austria). The study drug infusion will be started as either dexmedetomidine (1gram per kilogram over 10 min as a loading dose, followed by a maintenance infusion 0.2 to 1.5 grams per kilogram or propofol (started at 75gram per kilogram per minute and ranging from 12.5 to 125 gram per kilogram per minute titrated to maintain the Observer's Assessment of Alertness/Sedation Scale (OAA/SS) between 0-1. Intraoperative fluids will be restricted to 500 milliliter + 100mililiterml of Lactated Ringer's solution. At the onset of the procedure, the anesthesiologist will administer 0.7gram/kilogram bolus of fentanyl intravenous, followed by additional 25-50gram boluses for any patient movement to surgical stimulus. All patients will receive ondansetron 4 milligram IV 15-20 minutes prior to the end of surgery. Patients will receive glycopyrrolate 0.2 mg IV if HR decreases below 50 bpm. Postoperatively: In the recovery room, VRS for pain will be assessed upon admission and at 30 minute intervals thereafter. Analgesics will be administered according to the severity of the pain and degree of alertness.Vomiting and retching episodes.will be assessed at 30 minute intervals using a VRS, and patients with scores greater than 4 or those who request antiemetic treatment will be treated with metoclopramide 10 mg IV. Recovery from anesthesia and return of psychomotor ability will be assessed using the Modified Post Anesthesia Discharge Scoring System (MPADSS). A score of 8 or greater will indicate discharge readiness. Discharge readiness requires that a patient be awake and alert with stable vital signs, able to ambulate without assistance, and free of side effects. 24 hours after discharge. Times from end of surgery to oral intake and readiness for discharge, , and all adverse events and medications administered will be recorded. These data will be recorded by research staff blinded to the study group assignments. Subjects will be contacted by telephone 24 hours after surgery to obtain post-discharge data, including a repeat QoR-40 assessment.

Interventions

DRUGPlacebo Comparator

Placebo administration (.9 normal saline sterile)

DRUGActive Comparator

Administration of Dexmedetomidine

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* ASA I-II * Age: 18-64 years * Female * Surgery: Gynecologic hysteroscopy * Language: English speaking * Consent: Obtained

Exclusion criteria

* Pregnant or breast feeding * Significant arrhythmia or high degree atrioventricular nodal block * Significant hepatic or renal dysfunction * Chronic use or addiction to opiates or sedatives * History of heavy alcohol usage (\>4 drinks/day) * Psychiatric or emotional disorder * Chronic use of α2-agonists * Patients with OSA or BMI greater than 30 * Allergy to study drug or anesthetic medications utilized in the protocol

Design outcomes

Primary

MeasureTime frameDescription
The Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.Interoperative periodThe primary outcome will be the difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol. As described by mean and standard deviation.

Secondary

MeasureTime frameDescription
Time to Discharge24 HoursTime to discharge from the Post Anesthesia Care Unit or home or to hospital room.

Countries

United States

Participant flow

Recruitment details

Subjects were introduced to the study in a clinic setting and allowed to review the consent prior to their operative procedure.

Pre-assignment details

10 subjects were approached and all of the subjects agreed to participate.

Participants by arm

ArmCount
Placebo Comparator
Continuous infusion of placebo during operative procedure
6
Active Comparator
Administration of Dexmedetomidine
4
Total10

Baseline characteristics

CharacteristicActive ComparatorPlacebo ComparatorTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
4 Participants6 Participants10 Participants
Age Continuous41.5 years
STANDARD_DEVIATION 7.43
43.6 years
STANDARD_DEVIATION 8.4
42.8 years
STANDARD_DEVIATION 8.13
Region of Enrollment
United States
4 participants6 participants10 participants
Sex: Female, Male
Female
4 Participants6 Participants10 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 60 / 4
serious
Total, serious adverse events
0 / 60 / 4

Outcome results

Primary

The Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.

The primary outcome will be the difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol. As described by mean and standard deviation.

Time frame: Interoperative period

ArmMeasureValue (MEAN)Dispersion
Placebo ComparatorThe Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.11.8 Total Morphine Equivalents mgStandard Deviation 3.5
Active ComparatorThe Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.11.58 Total Morphine Equivalents mgStandard Deviation 4.79
Secondary

Time to Discharge

Time to discharge from the Post Anesthesia Care Unit or home or to hospital room.

Time frame: 24 Hours

ArmMeasureValue (MEAN)Dispersion
Placebo ComparatorTime to Discharge88.16 minutesStandard Deviation 30
Active ComparatorTime to Discharge115 minutesStandard Deviation 33.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026