Dexmedetomidine infusion during caesarean section under general anaesthesia: Evaluation of maternal awareness using BIS, maternal and neonatal outcomes

This study was approved by Suez Canal University's Institutional full Board committee (research #2859) on 28 June 2016 and written informed consent was obtained from all subjects participating in the trial. The trial was registered at Pan African Clinical Trial Registry (http://www.pactr.org) database (PACTR201802003114191, Date of registration: 26 February 2018). This manuscript adheres to the applicable CONSORT guidelines. This randomized blind clinical trial was registered on Pan African Clinical Trial Registry (www.pactr.org) database, with a trial ID (PACTR201802003114191).

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Peer review under responsibility of Egyptian Society of Anesthesiologists.

Figures & data

Fig. 1 flow chart of patient's participation progress throughout the study.

Table 1 Demographic data in both groups of the study.

Demographic data			Groups		P value
			Dex (n = 22)	Control (n = 22)
Age (years)			24.59 ± 4.18	22.45 ± 3.29	0.067(NS)
Chronic illness	HTN DM	N (%)	1 (4.5)	0	0.846(NS) 1(NS)
		N (%)	1 (4.5)	1 (4.5)
Weight (K.g)		Mean ± SD	88.4 ± 6.25	89.3 ± 5.63	0.615(NS)
Duration of surgery		Mean ± SD	51.59 ± 5.85	52.04 ± 5.70	0.795(NS)

NS non-significant difference (p value > 0.05).

^*Statistically significant difference (p value < 0.05).

Fig. 2 BIS values and heamodynamics in both groups of the study at different time intervals during surgery.

Table 2 MAC of Isoflurane at different time intervals.

MAC		Groups		P value
		Dex	Control
After induction	Mean ± SD	0.600 ± 0.000	0.600 ± 0.000	1.000(NS)
Skin incision	Mean ± SD	0.586 ± 0.035	0.627 ± 0.045	0.002^*
Retraction	Mean ± SD	0.577 ± 0.042	0.705 ± 0.021	0.000^*
Uterine incision	Mean ± SD	0.573 ± 0.045	0.705 ± 0.021	0.000^*
Fetal delivery	Mean ± SD	0.541 ± 0.050	0.673 ± 0.055	0.000^*
Uterine curettage	Mean ± SD	0.491 ± 0.029	0.645 ± 0.051	0.000^*
Uterine closure	Mean ± SD	0.445 ± 0.051	0.614 ± 0.035	0.000^*
Abdominal lavage	Mean ± SD	0.436 ± 0.058	0.591 ± 0.052	0.000^*
Peritoneum closure	Mean ± SD	0.414 ± 0.071	0.564 ± 0.065	0.000^*
Subcutaneous closure	Mean ± SD	0.309 ± 0.068	0.414 ± 0.120	0.001^*
Shutoff isoflurane	Mean ± SD	0.150 ± 0.080	0.186 ± 0.108	0.212(NS)
Skin closure	Mean ± SD	0.036 ± 0.065	0.055 ± 0.051	0.311(NS)

NS non-significant difference (p value > 0.05).

* Statistically significant difference (p value < 0.05).

Table 3 Apgar score in both groups of the study at 1 min and 5 min.

APGAR SCORE		Groups		P value
		Dex(n = 22)	Control(n = 22)
1 min	Mean ± SD	5.68 ± 0.71	5.26 ± 0.86	0.085 (NS)
5 min	Mean ± SD	9.08 ± 0.80	8.86 ± 0.49	0.278 (NS)

NS non-significant difference (p value > 0.05).

*Statistically significant difference (p value < 0.05).

Table 4 Alderete score, sedation score and postoperative analgesic needs of the two study groups at post anesthetic care unit (PACU).

ALDERETE SCORE			Groups		P value
			Dex(n = 22)	Control(n = 22)
15 min	Mean ± SD		7.86 ± 0.35	9.50 ± 0.51	0.000^*
30 min	Mean ± SD		10.00 ± 0.00	10.00 ± 0.00	1.000(NS)
Sedation score
Sedation 5	1	N (%)	0	17 (77.3)	0.000^*
	2	N (%)	12 (54.5)	5 (22.7)
	3	N (%)	10 (45.5)	0
Sedation 15	1	N (%)	0	22 (100)	0.000^*
	2	N (%)	22 (100)	0
Sedation 30	1	N (%)	22 (100)	22 (100)	1.000(NS)
Sedation 45	1	N (%)	22 (100)	22 (100)	1.000(NS)
Extra Fentanyl doses
N(%)			0	10 (45.5)	0.000^*

NS non-significant difference (p value > 0.05).

* Statistically significant difference (p value < 0.05).