Trial Outcomes & Findings for Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction (NCT NCT03793751)

Results Overview

Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The "Montreal Cognitive Assessment" (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

120 participants

Primary outcome timeframe

0-7 days

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	DEX Group Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.	CONTROL Group The Control Group will receive placebo infusion of normal saline.
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DEX Group n=60 Participants Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.	CONTROL Group n=60 Participants The Control Group will receive placebo infusion of normal saline.	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=99 Participants	20 Participants n=107 Participants	39 Participants n=206 Participants
Age, Categorical >=65 years	41 Participants n=99 Participants	40 Participants n=107 Participants	81 Participants n=206 Participants
Age, Continuous	68.28 Years STANDARD_DEVIATION 3.93 • n=99 Participants	68.48 Years STANDARD_DEVIATION 4.96 • n=107 Participants	68.38 Years STANDARD_DEVIATION 4.46 • n=206 Participants
Sex: Female, Male Female	36 Participants n=99 Participants	29 Participants n=107 Participants	65 Participants n=206 Participants
Sex: Female, Male Male	24 Participants n=99 Participants	31 Participants n=107 Participants	55 Participants n=206 Participants
Race/Ethnicity, Customized Indian	60 Participants n=99 Participants	60 Participants n=107 Participants	120 Participants n=206 Participants

PRIMARY outcome

Timeframe: 0-7 days

Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The "Montreal Cognitive Assessment" (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction.

Outcome measures

Outcome measures
Measure	DEX Group n=60 Participants Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.	CONTROL Group n=60 Participants The Control Group will receive placebo infusion of normal saline.
Number of Cases Developing POCD	10 Participants	21 Participants

SECONDARY outcome

Timeframe: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.

Population: Intraoperative Systolic Blood Pressure

Intraoperative Systolic Blood Pressure

Outcome measures

Outcome measures
Measure	DEX Group n=60 Participants Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.	CONTROL Group n=60 Participants The Control Group will receive placebo infusion of normal saline.
Systolic Blood Pressure T0	129.07 mmHg Standard Deviation 13.5	125.4 mmHg Standard Deviation 10.44
Systolic Blood Pressure T1	130.78 mmHg Standard Deviation 19.46	125.45 mmHg Standard Deviation 10.81
Systolic Blood Pressure T2	128.22 mmHg Standard Deviation 13.78	127.48 mmHg Standard Deviation 8.39
Systolic Blood Pressure T3	126.22 mmHg Standard Deviation 13.91	123.03 mmHg Standard Deviation 8.6
Systolic Blood Pressure T4	122.93 mmHg Standard Deviation 13.47	119.1 mmHg Standard Deviation 13.06
Systolic Blood Pressure T5	117.71 mmHg Standard Deviation 10.73	115.97 mmHg Standard Deviation 11.43
Systolic Blood Pressure T6	115.88 mmHg Standard Deviation 10.65	113.5 mmHg Standard Deviation 10.89
Systolic Blood Pressure T7	117.71 mmHg Standard Deviation 10.96	131.33 mmHg Standard Deviation 15.31
Systolic Blood Pressure T8	136.00 mmHg Standard Deviation 5.29	155.00 mmHg Standard Deviation 0

SECONDARY outcome

Timeframe: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.

Population: Diastolic Blood Pressure

Intraoperative Diastolic Blood Pressure

Outcome measures

Outcome measures
Measure	DEX Group n=60 Participants Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.	CONTROL Group n=60 Participants The Control Group will receive placebo infusion of normal saline.
Diastolic Blood Pressure T0	79.48 mmHg Standard Deviation 9.38	80.40 mmHg Standard Deviation 8.59
Diastolic Blood Pressure T1	78.92 mmHg Standard Deviation 9.06	78.15 mmHg Standard Deviation 11.19
Diastolic Blood Pressure T2	78.53 mmHg Standard Deviation 7.61	80.17 mmHg Standard Deviation 8.96
Diastolic Blood Pressure T3	75.15 mmHg Standard Deviation 9.34	77.02 mmHg Standard Deviation 10.28
Diastolic Blood Pressure T4	74.32 mmHg Standard Deviation 8.44	72.77 mmHg Standard Deviation 10.48
Diastolic Blood Pressure T5	72.69 mmHg Standard Deviation 7.78	70.43 mmHg Standard Deviation 11.96
Diastolic Blood Pressure T6	71.62 mmHg Standard Deviation 7.35	68.38 mmHg Standard Deviation 10.06
Diastolic Blood Pressure T7	71.79 mmHg Standard Deviation 6.97	78 mmHg Standard Deviation 7.81
Diastolic Blood Pressure T8	75.67 mmHg Standard Deviation 5.51	90.00 mmHg Standard Deviation 0

SECONDARY outcome

Timeframe: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.

Population: Intraoperative heart rate

Intraoperative Heart Rate

Outcome measures

Outcome measures
Measure	DEX Group n=60 Participants Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.	CONTROL Group n=60 Participants The Control Group will receive placebo infusion of normal saline.
Heart Rate T0	75.00 Beats/minute Standard Deviation 11.21	81.90 Beats/minute Standard Deviation 7.09
Heart Rate T1	74.80 Beats/minute Standard Deviation 11.37	82.02 Beats/minute Standard Deviation 6.84
Heart Rate T2	79.8 Beats/minute Standard Deviation 11.37	82.02 Beats/minute Standard Deviation 6.81
Heart Rate T3	77.97 Beats/minute Standard Deviation 11.27	82.65 Beats/minute Standard Deviation 6.57
Heart Rate T4	76.32 Beats/minute Standard Deviation 11.08	83.20 Beats/minute Standard Deviation 6.18
Heart Rate T5	76.15 Beats/minute Standard Deviation 10.57	84.00 Beats/minute Standard Deviation 6.10
Heart Rate T6	74.76 Beats/minute Standard Deviation 10.59	85.35 Beats/minute Standard Deviation 6.15
Heart Rate T7	70.17 Beats/minute Standard Deviation 10.46	86.67 Beats/minute Standard Deviation 9.24
Heart Rate T8	69.33 Beats/minute Standard Deviation 9.71	95.00 Beats/minute Standard Deviation 0

SECONDARY outcome

Timeframe: 0-7 days

Population: Insidence of adverse outcomes

Observation for any adverse effects

Outcome measures

Outcome measures
Measure	DEX Group n=60 Participants Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.	CONTROL Group n=60 Participants The Control Group will receive placebo infusion of normal saline.
Any Adverse Outcome	0 number of cases Standard Deviation 0	0 number of cases Standard Deviation 0

Adverse Events

DEX Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CONTROL Group

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.Deb Sanjay Nag

Tata Main Hospital, Tata Steel

Phone: +91-9431166582

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place