Trial Outcomes & Findings for Dexmedetomidine in Spinal Anesthesia (NCT NCT02155010)

Results Overview

We compare incidence rate of hypotension during infusion of dexmedetomidine

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

up to 3 hours

Results posted on

2016-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine Before Bupivacaine IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine	Dexmedetomidine After Bupivacaine IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine
Overall Study STARTED	37	37
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexmedetomidine in Spinal Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Before Spinal Anesthesia n=31 Participants IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine	After Spinal Anesthesia n=31 Participants IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine	Total n=62 Participants Total of all reporting groups
Age, Continuous	38.74 years STANDARD_DEVIATION 12.27 • n=5 Participants	35.87 years STANDARD_DEVIATION 11.22 • n=7 Participants	37.31 years STANDARD_DEVIATION 11.75 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 hours

We compare incidence rate of hypotension during infusion of dexmedetomidine

Outcome measures

Outcome measures
Measure	Before Spinal Anesthesia n=31 Participants IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine	After Spinal Anesthesia n=31 Participants IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine
Incidence of Hypotension	15 participants	5 participants

SECONDARY outcome

Timeframe: up to 3 days

We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores \>50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery.

Outcome measures

Outcome measures
Measure	Before Spinal Anesthesia n=31 Participants IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine	After Spinal Anesthesia n=31 Participants IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine
Patient's Anxiety State Anxiety Inventory (Preoperative)	43.65 points Standard Deviation 14.24	45.52 points Standard Deviation 12.01
Patient's Anxiety State Anxiety Inventory (discharge from PACU)	37.03 points Standard Deviation 10.51	38.55 points Standard Deviation 8.04
Patient's Anxiety State Anxiety Inventory (postoperative first day)	34.90 points Standard Deviation 9.03	34.55 points Standard Deviation 8.64

Adverse Events

Before Spinal Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

After Spinal Anesthesia

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

Ki Hwa Lee

Haeundae paik hospital, Inje University

Phone: 82-51-797-0421

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place