Placental Transfer and Neonatal Effects of Epidural Sufentanil and Fentanyl Administered with Bupivacaine during Labor

1995 ◽  
Vol 83 (2) ◽  
pp. 300-308. ◽  
Author(s):  
John R. Loftus ◽  
Harlan Hill ◽  
Sheila E. Cohen
Keyword(s):  
Placental Transfer ◽  
Plasma Concentrations ◽  
Double Blind ◽  
Epidural Bupivacaine ◽  
Neurobehavioral Testing ◽  
Neonatal Assessment ◽  
The Mean ◽  
Blood Gas Analyses ◽  
Group B ◽  
Fentanyl Group

Background This randomized double-blind investigation was designed to study the placental transfer and neonatal effects of epidural sufentanil and fentanyl infused with bupivacaine for labor analgesia. Methods Healthy parturient women (n = 36) received epidural bupivacaine alone (group B) or with fentanyl (group B-F) or sufentanil (group B-S). Group B received a 12-ml bolus of 0.25% bupivacaine followed by a 10 ml/h infusion of 0.125% bupivacaine. Groups B-F and B-S received a 12-ml bolus of 0.125% bupivacaine with 75 micrograms fentanyl or 15 micrograms sufentanil, respectively, followed by 10 ml/h of 0.125% bupivacaine with fentanyl 1.5 micrograms/ml or sufentanil 0.25 micrograms/ml. Maternal venous (MV) and umbilical arterial (UA) and umbilical venous (UV) bupivacaine and opioid plasma concentrations were determined. Neonatal assessment included Apgar scores, umbilical cord blood gas analyses, and neurobehavioral testing at delivery and at 2 and 24 h of life using the Neurologic and Adaptive Capacity Score (NACS). Results The mean total dose of fentanyl was 136.6 +/- 13.1 micrograms (SEM), and of sufentanil, 23.8 +/- 1.8 micrograms. Although administered in a ratio of 5.7:1, fentanyl and sufentanil MV plasma concentrations were in the ratio of 27:1. UV/MV ratios were 0.37 for fentanyl and 0.81 for sufentanil. Fentanyl was detected in most UA samples, whereas sufentanil was present in only one sample. Neonatal condition was good and generally similar in all groups, with the exception of a lower NACS at 24 h in group B-F. Conclusions Although the degree of placental transfer of sufentanil appeared greater than that of fentanyl, lower MV sufentanil concentrations resulted in less fetal exposure to sufentanil. The lower NACS at 24 h in group B-F may reflect the continued presence of fentanyl in the neonate.

Pharmacokinetics and Safety Assessment of Anti-HIV Dapivirine Vaginal Microbicide Rings with Multiple Dosing

2020 ◽  
Author(s):  
Lungwani Muungo
Keyword(s):  
Ex Vivo ◽  
Oral Treatment ◽  
Plasma Concentrations ◽  
Vaginal Ring ◽  
Vaginal Fluid ◽  
Cervical Tissue ◽  
Double Blind ◽  
Group A ◽  
Group B ◽  
Anti Hiv

Objectives: Self-administered vaginal rings are a promising method for delivery of topical anti-HIV microbicidesand might offer an adherence advantage over daily or coitally-dependent dosage forms such as gels. This trialassessed the safety and pharmacokinetic aspects of the Dapivirine Vaginal Ring-004 when worn as multiple rings oversequential periods of ring use by healthy, sexually-active, HIV-negative women.Methods: This double-blind trial was conducted among 48 women (18-40 years). Participants were randomlyassigned to two groups (A or B) and received (3:1) either the dapivirine or a placebo vaginal ring. Group A used tworings over a 56-day period and Group B used three rings over a 57-day period. Safety evaluations were conductedthroughout the trial. Dapivirine concentrations were measured in plasma, vaginal fluid and cervical tissue samplescollected during and after the 56 days (Group A) or 57 days (Group B) of vaginal ring use.Results: Ring-004 was safe and well tolerated in all participants. The pharmacokinetic profile demonstrated arapid increase in plasma and vaginal fluid concentrations and achieved concentrations in vaginal fluids and cervicaltissue well above the in vitro IC99 in cervical tissue (3.3 ng/mL) that were sustained for a 28 to 35-day ring use period(approximately 3000 times higher in vaginal fluids and 14 -1000 times higher in cervical tissue). Drug levels wereassociated with significant inhibitory activity of genital secretions against HIV ex vivo, a biomarker of pharmacodynamics.Individual plasma dapivirine concentrations did not exceed 553 pg/mL and were well below plasma concentrations atthe maximum tolerated dose for oral treatment (mean Cmax 2286 ng/mL).Conclusions: The consecutive use of several rings over a period of up to 57 days was safe and well tolerated, andPK data indicate that a single Ring-004 is likely to be protective for at least 35 days.

The role of tolvaptan in prevention of hyponatremia in patients undergoing transurethral resection of prostate surgery- A randomized double blind study

2021 ◽  
Vol 8 (2) ◽  
pp. 321-325
Author(s):  
Dinesh Kumar Singh ◽  
B B Baj ◽  
Vipin Goyal
Keyword(s):  
Transurethral Resection ◽  
Blind Study ◽  
Transurethral Resection Of Prostate ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

The aim of our study to determine the role of tolvaptan in prevention of hyponatremia in transurethral resection of prostate surgery. This is randomized double-blind study conducted in 60 ASA grade status 1 and 2 patients age group between 45-80 yrs undergoing TURP under spinal anaesthesia in urology operation theatre in Mahatma Gandhi hospital Jaipur after receiving permission from hospital ethical committee. A detailed history, complete physical examination and routine investigation were done for all patients followed by informed written consent was obtained. Patients are randomly divided into 2 groups. In group A -30 patients who received orally tab tolvaptan 15 mg and group B-30 patients who received orally tab multivitamin 2 hrs before surgery after doing electrolytes of the patients in the morning. In both groups age (in yrs), wt (in kg), ASA grade, volume of irrigating fluid (in litres), volume of prostate resected (in gm) and duration of surgery (in minutes) all demographic and surgical details data were compared. Electrolytes were compared in both groups pre and post-operatively and statistical analysis was done.There was significant difference in post-operative sodium level between the two groups (A and B). The mean level of sodium significantly reduced post-operatively in group –B (control grp). The mean level of sodium significantly increased post-operatively in group –A (tolvaptan grp). We conclude single dose of tolvaptan -15 mg found to effective in prevention of hyponatremia in patients undergoing TURP.

scholarly journals A Double-Blind Randomized Prospective Study Comparing Ondansetron with Droperidol in the Prevention of Emesis following Strabismus Surgery

1995 ◽  
Vol 23 (4) ◽  
pp. 438-443 ◽  
Author(s):  
A. Davis ◽  
S. Krige ◽  
D. Moyes
Keyword(s):  
Recovery Time ◽  
Strabismus Surgery ◽  
Double Blind Study ◽  
Double Blind ◽  
Oral Fluids ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
To Receive ◽  
Mean Time

A prospective double-blind study was conducted to compare the anti-emetic efficacy of ondansetron and droperidol in preventing postoperative emesis following strabismus surgery. A sample size of 213 patients was divided into three equal groups to receive ondansetron 150 μg/kg (Group A), ondansetron 75 μg/kg (Group B), or droperidol 75 fig/kg (Group C). All patients received a standardized anaesthetic technique. All episodes of emesis, recovery time, and time to tolerating oral fluids were recorded. The incidence of emesis during 24 hours was Groups A and B 19.7%, and Group C 28.2%. The lower incidence of emesis recorded by the ondansetron groups compared with the droperidol group was not statistically significant. Ondansetron at 75 μg/kg was as effective as 150 μg/kg in reducing emesis when compared with droperidol. Mean time to discharge from the recovery room was 75.3 minutes (Group A), 44.4 minutes (Group B), and 41.0 minutes (Group C). The mean time to tolerating oral fluids was 356.5 minutes (Group A), 402.8 minutes (Group B), and 378.1 minutes (Group C). There was no statistical difference in discharge times from recovery or time to tolerating oral fluids in any of the three groups.

Effect of Epidural Fentanyl on Neonatal Respiration 

1998 ◽  
Vol 89 (1) ◽  
pp. 79-85 ◽  
Author(s):  
Jackie Porter ◽  
Edric Bonello ◽  
Felicity Reynolds
Keyword(s):  
Carbon Dioxide ◽  
Carbon Dioxide Tension ◽  
Epidural Fentanyl ◽  
Transcutaneous Oxygen ◽  
Fentanyl Concentration ◽  
Epidural Bupivacaine ◽  
Acid Base Status ◽  
The Mean ◽  
To Receive ◽  
Fentanyl Group

Background The addition of opioids to epidural infusions for laboring mothers may reintroduce the problem of neonatal depression seen with systemic opioids. The authors studied neonatal respiration and neurobehavior in newborns of mothers randomized to receive epidural analgesia with or without fentanyl. Methods One hundred thirty-eight women in labor received loading doses of plain bupivacaine. When pain-free, they received an infusion of either 0.125% bupivacaine alone or 0.0625% bupivacaine with 2.5 microg/ml fentanyl. After delivery, transcutaneous oxygen tension and carbon dioxide tension were recorded in the newborns every 10 s until 90 min after delivery using a transcutaneous oxygen-carbon dioxide monitor. Umbilical venous and arterial acid-base status, Apgar scores, and Neurologic and Adaptive Capacity Scores 2 h and 24 h after delivery were measured. The umbilical venous plasma fentanyl concentration was correlated with indices of neonatal respiration and welfare in the fentanyl group. Results One hundred fourteen newborns delivered vaginally were studied. In the fentanyl group, the mean (range) maternal dose of fentanyl was 184 microg (range, 53-400), and the umbilical venous fentanyl concentration was 0.077 ng/ml (range, <0.021 to 0.244). There were no significant differences between the groups for any indices of neonatal respiration or neonatal welfare, and the plasma fentanyl concentration did not correlate with any of these indices. Conclusions The results suggest that fentanyl added to epidural bupivacaine infusions during labor does not depress neonatal respiration or adversely affect neurobehavioral scores and other indices of neonatal welfare.

scholarly journals Comparison of Postoperative Analgesic Effects Between Nalbuphine and Fentanyl in Children Undergoing Adenotonsillectomy: A Prospective, Randomized, Double-Blind, Multicenter Study

2020 ◽  
Vol 11 ◽  
Author(s):  
Fang Chen ◽  
Cheng-Yu Wang ◽  
Jianmin Zhang ◽  
Fang Wang ◽  
Mazhong Zhang ◽  
...  
Keyword(s):  
Multicenter Trial ◽  
Double Blind ◽  
Rescue Dose ◽  
Analgesic Effects ◽  
Extubation Time ◽  
Medical Facilities ◽  
The Mean ◽  
Waking Up ◽  
Pacu Stay ◽  
Fentanyl Group

Objective: There is no universal agreement on optimal pharmacological regimens for pain management during surgeries. The aim of this study to compare the postoperative analgesic effects of nalbuphine with fentanyl in children undergoing adenotonsillectomy.Design, Setting, Participants: We conducted a prospective, randomized, double-blind, non-inferiority and multicenter trial in 311 patients admitted to four different medical facilities in China from October 2017 to November 2018.Main Outcome Measure: The primary outcome was postoperative pain score. The secondary outcomes were as follows: the numbers of patients who developed moderate or severe pain (FLACC ≥4 points); time to first rescue analgesic top up and the actual number of rescue pain medicine given in pain control in post-anesthesia care unit (PACU), and additional analgesics requirement (received ≥2 rescue analgesics or/and other analgesics except study medications administered in PACU and ward); emergence and extubation time; Waking up time; time of PACU stay, and other side effects (desaturation, nausea/vomiting etc.).Results: A total of 356 children were screened and 322 patients were randomized. The mean age was 5.8 (5.5, 6.1) in the nalbuphine group and 5.6 (5.3, 5.8) in the fentanyl group (p = 0.2132). FLACC score of nalbuphine group was lower than that of fentanyl group upon patients' arrival at PACU (p < 0.05). The time to first required rescue dose of pain drug for nalbuphine group was longer than for the fentanyl group (2.5 vs 1.2 h, p < 0.0001). Only one patient (0.6%) in nalbuphine group presented a slow respiratory rate (RR) at 9/min while 29 patients (18.5%) in fentanyl group developed slow RR ≤10/min in PACU. Meanwhile, SpO2 was lower in the fentanyl group at 10 min after patients’ arrival in PACU (p < 0.05). The other profiles observed from these two drug groups were similar.Conclusion: Nalbuphine provided better pain relief with minimal respiration depression than fentanyl in children undergoing Adenotonsillectomy.

A COMPARISON BETWEEN INTRATHECAL NALBUPHINE VERSUS FENTANYL AS AN ADJUVANT WITH 0.5% HYPERBARIC BUPIVACAINE FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LOWER SEGMENT CESAREAN SECTION

2021 ◽  
Vol 5 (8) ◽  
Author(s):  
Mukesh Choudhary ◽  
Neeti Mahla
Keyword(s):  
Cesarean Section ◽  
Postoperative Analgesia ◽  
Motor Block ◽  
Sensory Block ◽  
Hyperbaric Bupivacaine ◽  
Double Blind ◽  
Lower Segment Cesarean Section ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Subarachnoid block is the preferred anesthesia for cesarean section, being simple to perform and economical with rapid onset. This study aims to compare the postoperative analgesia of intrathecal nalbuphine and fentanyl as adjuvants to bupivacaine in cesarean section. Methods: A prospective, randomized, double?blind, and comparative study was conducted on 120 patients of American Society of Anesthesiologists (ASA) physical status I and II. These patients were randomized into three groups with fifty patients in each group. Group A received 2 ml of 0.5% hyperbaric bupivacaine (10 mg) plus 0.4 ml nalbuphine (0.8 mg), Group B received 2 ml of 0.5% hyperbaric bupivacaine (10 mg) plus 0.4 ml fentanyl (20 ?g), and Group B received 2 ml of 0.5% hyperbaric bupivacaine (10 mg) plus 0.4 ml of normal saline. Results: The mean duration of sensory block was 107.32 ± 5.36 min in Group A, 111.23 ± 4.23 min in Group B, and 85.69 ± 2.31 min in Group C. The mean duration of motor block (time required for motor block to return to Bromage’s Grade 1 from the time of onset of motor block) was 152.02 ± 3.12 min in Group A, 151.69± 2.36 min in Group B, and 122.12 ± 2.32 min in Group C. Conclusion: We concluded that intrathecal nalbuphine prolongs postoperative analgesia maximally and may be used as an alternative to intrathecal fentanyl in cesarean section. Keywords: Nalbuphine, Bupivacaine, Fentanyl.

COMPARISON OF DEXMEDETOMIDINE AND FENTANYL ON INTUBATION CONDITIONS DURING AWAKE FIBREOPTIC BRONCHOSCOPIC INTUBATION- A RANDOMISED DOUBLE BLIND STUDY.

2021 ◽  
pp. 1-2
Author(s):  
Asha .A ◽  
E. Arunmozhi
Keyword(s):  
Heart Rate ◽  
Study Drug ◽  
Sedation Score ◽  
Double Blind ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
Post Intubation ◽  
Ramsay Sedation Score ◽  
Mean Heart Rate

INTRODUCTION:Awake Fibreoptic Intubation is indicated in patients with anticipated diffcult airway, failed tracheal intubation, unstable cervical spine injury.Drugs used for conscious sediation includes Benzodiazepines, opioids, Propofol, either alone or in combination. All these drugs, though results in favourable intubating conditions, may also result in upper airway obstruction, hypoventilation, difcult airway instrumentation and oxygen desaturation. In order to address and overcome these issues, we compared the effects of parenteral dexmedetomidine and fentanyl on favourable conditions during awake breoptic bronchoscopic intubation. MATERIALS AND METHODS:A prospective,double blind,randomised study. 60 patients belonging to age group 25 to 60 years, ASA PS I & II posted for elective surgery under general anaesthesia with endotracheal intubation were randomly allocated into two groups, Group A(n=30) received injection dexmedetomidine, Group B(n=30) received injection fentanyl before awake breoptic bronchoscopic intubation. Hemodynamic parameters, cough score, postintubation tolerance score, ramsay sedation score were noted in both groups. The observed datas were analysed by SPSS version 21.0 software. RESULT: Demographic variable such as age,weight,ASA physical status were comparable in both the groups. The mean heart rate at 5mins,10mins after administration of study drug,intubation, 5mins postintubation are 76.73±5.51,73.63±5.99,76.37±8.11 and 75.03±7.94 respectively in Group A.The mean heart rate at 5mins,10mins after administration of study drug,intubation, 5mins postintubation are 78.57±5.04,76.93±5.11,103.30±4.21 and 99.37±4.02 respectively.The mean MAP at 5mins,10 mins after administration of study drug,intubation,5 mins post intubation are 86.80±2.33,85.77 ±2.56,87.83 ±5.73 and 87.30 ± 2.52mmHg respectively in Group A.The mean MAP at 5mins,10mins after administration of study drug,intubation,5 mins post intubation are 87.37±3.58,85.63 ±3.58,107.80 ±2.59 and 105.00 ±2.52 mmHg respectively. The post intubation SpO2 was 97.10 ±1.77 and 93.43± 1.17 % for Group A and Group B respectively.In Group A mean Ramsay sedation score is 2.87± 0.43 and in Group B the mean is 2.13 ±0.35. CONCLUSION:Dexmedetomidine group showed better hemodynamic stability and tolerance to awake endotracheal tube insertion through breoptic bronchoscope.Dexmedetomidine provides favourable intubating conditions during awake breoptic bronchoscope procedures with adequate sedation and without desaturation than fentanyl.

EFfect Of Platelet Aggregation Inhibitor On Foetal Outcome In Cases Of Eph Gestosis

1981 ◽  
Author(s):  
N Bhattacharya ◽  
S Bhattacharya ◽  
K Mukherjee ◽  
N Bose ◽  
B Das ◽  
...  
Keyword(s):  
Platelet Aggregation ◽  
Diastolic Pressure ◽  
Platelet Aggregation Inhibitor ◽  
Double Blind ◽  
Placental Perfusion ◽  
Group A ◽  
Foetal Outcome ◽  
The Mean ◽  
Aggregation Inhibitor ◽  
Group B

42 mothers with clinical features of mild to moderate specific gestosis (Oedema, Proteinuria, Hypertension) with mean age 29.6±2.8 yrs SD, mean diastolic pressure at 28 weeks 98±4.4, mean parity 2.1±1.1, were enrolled in a placebo controlled double blind trial to see the effect of Dipyridamole (a platelet aggregation inhibitor mainly) in 100 mg t.i.d. on the augmentation of the placental perfusion, by changing the microplatelet thrombi, from 28 weeks up to term. Mothers randomized and grouped equally. Group A received placebo and Group B received drugs in the schedule mentioned. Two cases started premature labour (Group A) and excluded from study. The mean foetal wt in Group B 2700±67 and in Group A 2462±142, expressed in Gms with SD. Fibrinoid area stained with Phosphotungstic acid Aniline Blue of Mallory, was estimated for point counting of W. Ahere (The Placenta, pp. 83-84, Ed. P. Gruenwald, MTP, 1975). The result of the counting suggested a positive physiological correlationship with the outcome of the foetal weight in this tentative study.

Effect of aminophylline on plasma and urinary catecholamine levels during heavy leg exercise in healthy young men

1989 ◽  
Vol 76 (3) ◽  
pp. 255-260 ◽  
Author(s):  
Å. Wennmalm ◽  
E. Karwatowska-Prokopczuk ◽  
M. Wennmalm
Keyword(s):  
Plasma Level ◽  
Plasma Concentrations ◽  
Young Men ◽  
Double Blind ◽  
Urinary Catecholamines ◽  
Sympathoadrenal Activity ◽  
Basal Plasma ◽  
Leg Exercise ◽  
The Mean ◽  
Exercise Induced

1. Methylxanthines have been shown to elevate the basal plasma level and/or urinary excretion of noradrenaline (NA) and adrenaline (ADR) in healthy subjects. The present study addressed the hypothesis that the methylxanthine aminophylline also augments plasma and urinary catecholamines during increased sympathoadrenal activity. 2. Eleven healthy young men performed a maximal 2 h bicycle exercise twice, after double-blind intravenous administration of placebo or aminophylline. Femoral venous plasma and urinary concentrations of NA and ADR were analysed in samples representing basal state, exercise and recovery, using liquid chromatography with electrochemical detection. 3. Leg exercise induced eight- and six-fold increases in the plasma concentrations of NA and ADR, respectively, and seven- and four-fold increases in the urinary concentrations of NA and ADR, respectively, indicating that sympathoadrenal activity was considerably elevated. 4. After aminophylline (mean plasma concentration 20–35 μmol/l), the plasma concentrations of NA (P < 0.001) and ADR (P < 0.05) were independently higher at rest, during exercise and during recovery, in comparison to after placebo; the mean exercise plasma level of NA was increased by the drug from 13 ± 1 to 21 ± 2 nmol/l and the corresponding level of ADR from 2.1 ± 0.4 to 2.9 ± 0.5 nmol/l. Also urinary NA (P < 0.01) and ADR (P < 0.05) were elevated by aminophylline; the exercise concentrations of NA in the urine were 75 ± 8 and 97 ± 10 μmol/mol of creatinine after placebo and aminophylline, respectively, and the corresponding levels of ADR were 12 ± 3 and 16 ± 3 μmol/mol of creatinine, respectively. 5. These data indicate that the facilitating effect of methylxanthines on plasma and urinary NA and ADR is present also when the sympathoadrenal activity is elevated by physical exercise.

scholarly journals Efficacy of Addition of Fentanyl to Epidural Bupivacaine on Postoperative Analgesia after Thoracotomy for Lung Resection in Infants

2008 ◽  
Vol 109 (5) ◽  
pp. 890-894 ◽  
Author(s):  
Arjunan Ganesh ◽  
N Scott Adzick ◽  
Travis Foster ◽  
Giovanni Cucchiaro
Keyword(s):  
Side Effects ◽  
Lung Resection ◽  
Epidural Fentanyl ◽  
Double Blind Study ◽  
Double Blind ◽  
Rescue Dose ◽  
Pain Scores ◽  
Epidural Bupivacaine ◽  
Group B ◽  
To Receive

Background The authors evaluated the efficacy of adding fentanyl to epidural bupivacaine in infants up to 6 months of age after a thoracotomy in a prospective, randomized, double-blind study. The primary outcome was the total amount of rescue doses of intravenous nalbuphine in the first 24 h after surgery. Secondary outcomes included (1) time to first rescue dose of nalbuphine, (2) pain scores, and (3) behavior scores. Methods Thirty-two infants were randomly assigned to receive an epidural infusion containing 0.1% bupivacaine (group B; n = 16) or 0.1% bupivacaine and 2 microg/ml fentanyl (group BF; n = 16). Patients were evaluated up to 24 h after surgery for pain; amount of analgesic rescues and time to first rescue; pain scores; behavior scores (five-item behavior score); and complications, including respiratory depression, oxygen requirement, vomiting, and urinary retention. Results The two groups had similar demographics. Nalbuphine consumption (P = 0.001) and pain scores (P &lt; 0.001) in the first 24 h were significantly decreased in group BF compared with group B. The time to first analgesic rescue was significantly longer in group BF (P = 0.005). The five-item behavior score was significantly better in group BF than in group B (P = 0.01). The incidence of side effects, the time to first successful feeding, and the time to discharge were similar in both groups. Conclusions Addition of 2 microg/ml epidural fentanyl to 0.1% bupivacaine results in improved postthoracotomy analgesia without any increase in side effects, compared with 0.1% bupivacaine, in infants up to 6 months of age.

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