Trial Outcomes & Findings for Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role? (NCT NCT03338400)

Last Updated: 2021-04-14

Results Overview

The primary aim is to evaluate whether standard administration of Dexamethasone at the time of anesthesia induction in patients undergoing vaginal reconstructive surgery would result in improved Quality of Recovery. The QoR-40 has 40 items that consider early postoperative health status of patients. These items cover five dimensions including emotional state (9 items), physical comfort (12 items), patient support (7 items), physical independence (5 items) and pain (7 items). All items are rated on a five-point Likert scale from one (worst) to five (best). All negative items were reversed to ease the interpretation. The total score (global score) was computed by summing all items. The minimum and maximum possible scores were 40 and 200, respectively.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

24 hours

Results posted on

2021-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Dexamethasone Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.	Normal Saline The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Overall Study STARTED	25	26
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexamethasone Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.	Normal Saline The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone n=24 Participants Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.	Normal Saline n=24 Participants The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
Body Mass Index	26 kg/m2 n=5 Participants	28 kg/m2 n=7 Participants	27 kg/m2 n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	Dexamethasone n=24 Participants Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.	Normal Saline n=24 Participants The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Questionnaire: Quality of Recovery 40	174 score on a scale Standard Deviation 14.49	167 score on a scale Standard Deviation 16.02

SECONDARY outcome

Timeframe: 24 hrs

Population: patients with \>50 on nausea scale

Clinically important nausea \>50

Outcome measures

Outcome measures
Measure	Dexamethasone n=24 Participants Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.	Normal Saline n=22 Participants The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Nausea, Vomiting	2 participants	2 participants

SECONDARY outcome

Timeframe: until 6 weeks

Number of UTIs diagnosed in each group

Outcome measures

Outcome measures
Measure	Dexamethasone n=24 Participants Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.	Normal Saline n=22 Participants The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Urinary Tract Infections	1 participants	2 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Number or ER visits post-op

Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.

Outcome measures

Outcome measures
Measure	Dexamethasone n=24 Participants Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.	Normal Saline n=22 Participants The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Readmissions	4 participants	1 participants

SECONDARY outcome

Timeframe: 24 hours

Population: Pain score from 0-10

numerical pain scale ranges from 0 to 10, where lower scores represent less pain.

Outcome measures

Outcome measures
Measure	Dexamethasone n=24 Participants Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.	Normal Saline n=22 Participants The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Pain Level	6.04 score on a scale Standard Deviation 2.8	4.77 score on a scale Standard Deviation 2.59

Adverse Events

Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Ossin

Cleveland Clinic Florida

Phone: 954-659-5559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place