Trial Outcomes & Findings for Quality of Recovery After Dexamethasone, Ondansetron or Placebo Intrathecal Morphine Administration (NCT NCT03035942)

NCT ID: NCT03035942

Last Updated: 2020-03-19

Results Overview

Quality of Recovery Questionnaire (QoR-40). Minimum score 40 (very poor quality of recovery) and maximun score 200 (excellent quality of recovery). Higher scores mean better outcome

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 135 participants
• Primary outcome timeframe: Twenty four hours after surgery by a blinded investigator
• Results posted on: 2020-03-19

Participant Flow

Participant milestones

Measure	O Group Ondansetron 4 mg Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	D Group Dexamethasone 8 mg Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	S Group Normal saline (5 mL total volume) Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Overall Study STARTED	45	45	45
Overall Study COMPLETED	37	41	40
Overall Study NOT COMPLETED	8	4	5

Reasons for withdrawal

Measure	O Group Ondansetron 4 mg Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	D Group Dexamethasone 8 mg Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	S Group Normal saline (5 mL total volume) Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Overall Study Adverse Event	8	4	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	O Group n=37 Participants Ondansetron 4 mg Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	D Group n=41 Participants Dexamethasone 8 mg Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	S Group n=40 Participants Normal saline (5 mL total volume) Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	Total n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=41 Participants	0 Participants n=40 Participants	0 Participants n=118 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=37 Participants	41 Participants n=41 Participants	40 Participants n=40 Participants	118 Participants n=118 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants	0 Participants n=41 Participants	0 Participants n=40 Participants	0 Participants n=118 Participants
Age, Continuous	34 years n=37 Participants	40 years n=41 Participants	35 years n=40 Participants	40 years n=118 Participants
Sex: Female, Male Female	13 Participants n=37 Participants	11 Participants n=41 Participants	11 Participants n=40 Participants	35 Participants n=118 Participants
Sex: Female, Male Male	24 Participants n=37 Participants	30 Participants n=41 Participants	29 Participants n=40 Participants	83 Participants n=118 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Brazil	37 participants n=37 Participants	41 participants n=41 Participants	40 participants n=40 Participants	118 participants n=118 Participants
ASA status Physical status ASA 1 (health person)	23 Participants n=37 Participants	21 Participants n=41 Participants	11 Participants n=40 Participants	55 Participants n=118 Participants
ASA status Physical status ASA 2 (mild systemic disease)	14 Participants n=37 Participants	20 Participants n=41 Participants	29 Participants n=40 Participants	63 Participants n=118 Participants
Body mass index	25 kg/m^2 n=37 Participants	26 kg/m^2 n=41 Participants	27 kg/m^2 n=40 Participants	26 kg/m^2 n=118 Participants

PRIMARY outcome

Timeframe: Twenty four hours after surgery by a blinded investigator

Quality of Recovery Questionnaire (QoR-40). Minimum score 40 (very poor quality of recovery) and maximun score 200 (excellent quality of recovery). Higher scores mean better outcome

Outcome measures

Measure	O Group n=37 Participants Ondansetron 4 mg Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	D Group n=41 Participants Dexamethasone 8 mg Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	S Group n=40 Participants Normal saline (5 mL total volume) Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Quality of Recovery	184 Score on a scale Interval 179.0 to 195.0	187 Score on a scale Interval 181.0 to 196.0	185 Score on a scale Interval 176.0 to 196.0

SECONDARY outcome

Timeframe: 4h

The occurrence of PONV will be registered during the PACU

Outcome measures

Measure	O Group n=37 Participants Ondansetron 4 mg Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	D Group n=41 Participants Dexamethasone 8 mg Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	S Group n=40 Participants Normal saline (5 mL total volume) Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Nausea and Vomiting During PACU Staying	3 Participants	9 Participants	9 Participants

SECONDARY outcome

Timeframe: 24 hours

The occurrence of localized or generalized itching (patients who answered yes or no)

Outcome measures

Measure	O Group n=37 Participants Ondansetron 4 mg Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	D Group n=41 Participants Dexamethasone 8 mg Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	S Group n=40 Participants Normal saline (5 mL total volume) Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Number of Participants With Pruritus	4 Participants	7 Participants	8 Participants

SECONDARY outcome

Timeframe: 24 hours

Pain were assessed every 15 minutes during postanesthesia care unit, where zero meant no pain and 10 the worst imaginable pain (higher values represent worse outcome). Twenty four hours after surgery, patients were asked to describe the highest pain score (NRS) during ward stay.

Outcome measures

Measure	O Group n=37 Participants Ondansetron 4 mg Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	D Group n=41 Participants Dexamethasone 8 mg Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	S Group n=40 Participants Normal saline (5 mL total volume) Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Pain During Postanesthesia Care Unit and Ward Stay (Numeric Rating Scale - NRS)	0 Score on a scale (NRS) Interval 0.0 to 5.0	5 Score on a scale (NRS) Interval 3.0 to 7.0	2 Score on a scale (NRS) Interval 0.0 to 6.0

Adverse Events

D Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

O Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

S Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	D Group n=45 participants at risk Dexamethasone 8 mg Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	O Group n=45 participants at risk Ondansetron 4 mg Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.	S Group n=45 participants at risk Normal saline (5 mL total volume) Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Surgical and medical procedures Fail of spinal anesthesia	8.9% 4/45 • Number of events 4 • One week The occurrence of fail of spinal anesthesia, allergic reactions, urinary retention, respiratory depression were recorded.	17.8% 8/45 • Number of events 8 • One week The occurrence of fail of spinal anesthesia, allergic reactions, urinary retention, respiratory depression were recorded.	11.1% 5/45 • Number of events 5 • One week The occurrence of fail of spinal anesthesia, allergic reactions, urinary retention, respiratory depression were recorded.

Additional Information

Dr. Eduardo Toshiyuki Moro

Pontificia Catholic University of Sao Paulo

Phone: +5515997728015

Email: edumoro85@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place